Intra-Abdominal Hypertension and the Abdominal Compartment Syndrome: International Guidelines
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Intra-abdominal Hypertension and the Abdominal Compartment Syndrome: Updated Consensus Definitions and Clinical Practice Guidelines from the World Society of the Abdominal Compartment Syndrome
Andrew W. Kirkpatrick, MD, MHSc, FRCSC, FACS1 Jan De Waele, MD, PhD3 Derek J. Roberts, MD2 Roman Jaeschke, MD, MSc, FRCPC4 Manu LNG Malbrain, MD, PhD5 Bart De Keulenaer, MD6 Juan Duchesne, MD, FACS, FCCP7 Martin Bjorck, MD, PhD8 Ari Leppaniemi, MD, PhD9 Janeth C. Ejike, MD10 Michael Sugrue, MD11 Michael Cheatham, MD, FACS12 Rao Ivatury, MD13 Chad G. Ball, MD, MSc, FRCSC14 Annika Reintam Blaser, MD, PhD 15 Adrian Regli, MD, FMH, EDIC, FCICM16 Zsolt J. Balogh, MD, PhD FRACS, FACS17 Scott D’Amours, MD, FRCSC18 Dieter Debergh, MSc, RN19 Gordon H. Guyatt, MD, MSc, FRCPC20 Mark Kaplan, MD, FACS 21 Edward Kimball, MD22 Claudia Olvera, MD23 And the Pediatric Guidelines Sub-Committee
Address for responsible correspondence and reprints;
1Andrew W Kirkpatrick CD MD MHSc FRCSC FACS, Regional Trauma Services, EG 23 Foothills Medical Centre, Calgary, Alberta, Canada, T2N 2T9; [email protected] 403-944-2888 and FAX 403-944-8799
This manuscript was commissioned and supported by the World Society of the Abdominal Compartment Syndrome (www.wsacs.org)
1 Author Affiliations
1Andrew W. Kirkpatrick, CD, MD, MHSc, FRCSC, FACS, Regional Trauma Services, EG 23 Foothills Medical Centre, Calgary, Alberta, Canada, T2N 2T9; [email protected] 403-944-2888 and FAX 403-944-8799 2Jan De Waele, MD, PhD, Department of Critical Care Medicine, Ghent University Hospital and Ghent Medical School, Ghent, Belgium. [email protected]
3Derek J. Roberts, MD, Departments of Surgery and Community Health Sciences, University of Calgary, Calgary, Alberta, T2N 5A1; [email protected] 4Roman Jaeschke, MD, MSc, Professor, Departments of Medicine and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada L8P 3B6. [email protected] 5Manu ML Malbrain, MD, PhD, ICU and high care burn unit director, ZNA Stuivenberg, Lange Beeldekensstraat 267, B-2060 Antwerpen 6, Belgium [email protected]
6B L De Keulenaer, MD, FCICM, Fremantle Hospital, Intensive Care Unit, Alma Street, PO Box 480, Fremantle 6958,WA, Australia; [email protected]
7Juan Duchesne, MD, Director Tulane Surgical Intensive Care Unit, Section of Trauma and Critical Care Surgery, Division of Surgery, Anesthesia and Emergency Medicine, 1430 Tulane Ave., SL-22, New Orleans LA 70112-2699. [email protected]
8Martin Bjorck, MD, PhD, Professor of Vascular Surgery, Institution of Surgical Sciences, Uppsala University, SE 751 85 Uppsala, Sweden [email protected]
9Ari Leppäniemi, MD, PhD, Department of Abdominal Surgery, Meilahti hospital, University of Helsinki, Haartmaninkatu 4, PO Box 340, 00029 HUS, Finland; [email protected]
10J Chiaka Ejike, MD, Loma Linda University Children’s Hospital, 11175 Campus Street, Ste A1117, Loma Linda, CA; [email protected]
11Michael Sugrue, MB BCh, BAO, MD, FRCSI, FRACS, Department of Surgery Letterkenny Hospital Donegal Ireland and University College Hospital Galway Ireland. [email protected]
12Michael L. Cheatham, MD, FACS, FCCM, Department of Surgical Education, 86 West Underwood St, Suite 201, Orlando, FL, 32806; [email protected]
13Rao Ivatury MD, Medical College of Virginia, 417 11 St, Richmond, Virginia; [email protected]
14Chad G. Ball, MD, FACS, Regional Trauma Services, EG 23 Foothills Medical Centre,
2 Calgary, Alberta, Canada, T2N 2T9, [email protected]
15Annika Reintam Blaser, MD, PhD, Clinic of Anaesthesiology and Intensive Care, University of Tartu, Puusepa 8, Tartu 51014, Estonia. [email protected]
16Adrian Regli, MD, FMH, EDIC, FCICM Fremantle ospital, Intensive Care Unit, Alma Street, PO Box 480, Fremantle 6958, WA, Australia. Associate Professor, School of Medicine and Pharmacology, Crawley WA, and The University of Notre Dame, Fremantle, Australia; [email protected]
17Zsolt Balogh, MD, PhD, University of Newcastle, John Hunter Hospital, Newcastle, New South Wales 2310, Australia ; [email protected]
18Scott D’Amours, MD, FRCSC, Trauma Department Liverpool Hospital, Locked Bag 1871, Liverpool, New South Wales, Australia, BC 2170. [email protected]
19Dieter Debergh, MSc, RN, Department of Intensive Care, Ghent University Hospital, B- 9000 Ghent, Belgium; [email protected]
20Gordon Guyatt, MD, MSc, Department of Medicine, McMaster University, Hamilton, ON, Canada L8P 3B6, Department of Clinical Epidemiology and Biostatistics, McMaster University; [email protected]
21Edward Kimball, MD, Department of Surgery, 50 N Medical Drive, Salt Lake City, Utah; [email protected]
22Mark J Kaplan, MD, FACS, Albert Einstein Medical Center, Philadelphia Pa 19141, Associate Professor of Surgery Jefferson School of Medicine, Associate Chairman of Surgery Albert Einstein Medical Center, Philadelphia Chairman Division Of Trauma and Surgical Critical Care Albert Einstein Medical Center, Philadelphia. [email protected]
23Dr. Claudia I. Olvera, Intensivist. The American British Cowdray Medical Center. Professor of Medicine. Universidad Anahuac. Mexico City. [email protected]
Disclosures
Andrew W Kirkpatrick: Has served on an Advisory Board for Lantheus Medical, Boston, MA, discussing the use of ultrasound contrast media. He has also received an unrestricted research grant from Kinetic Concepts Incorporated to conduct a prospective randomized trial in open abdomen management. He also received the unrestricted use of a Sonosite NanoMaxx ultrasound machine for research use from the Sonosite Corporation. Jan De Waele: Consultancy for Kinetic Concepts Incorporated and Smith and Nephew Limited Derek Roberts: No conflicts of interest.
3 Roman Jaeschke: No COI over the last 5 years. Manu LNG Malbrain: Member of the medical advisory board of Pulsion Medical Systems; Consultancies for Kinetic Concepts Incoporated, Holtech Medical, Fresenius-Kabi, and ConvaTec. Bart De Keulenaer: No conflicts of interest. Juan Duchesne: No conflicts of interest. Martin Bjorck: Received an unrestricted research grant from the Kinetic Concepts Incorporated Corporation in 2006. Ari Leppäniemi: No conflicts of interest during last 2 years. Michael Sugrue: has received a speaking Honorarium in from Kinetic Concepts Incorporated in 2009 and from Smith and Nephew Ltd in 2010-2011. Janeth C Ejike: Received an unrestricted educational grant from Wolfe Tory, Incorporated in 2011. Michael Cheatham: Rao Ivatury: Chad G Ball: No conflicts of interest Annika Reintam Blaser: No conflicts of interest. Adrian Regli: No conflicts of interest. Zsolt Balogh: No conflicts of interest. Scott D’Amours: No conflicts of interest. Dieter Debergh: No conflicts of interest. Gordon H Guyatt: Mark Kaplan: Serves as a speaker and consultant to the KCI corporation Edward Kimball: No conflicts of interest. Claudia Olvera: No conflicts of interest.
4 Short running head: Updated Consensus Definitions and Management Guidelines for IAH and ACS
Mini-Abstract: The World Society of the Abdominal Compartment Syndrome conducted a Consensus Conference and utilized the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to update previously established Definitions and Management statements for intra-abdominal hypertension and the abdominal compartment syndrome.
5 Abstract
Objective: To update the World Society of the Abdominal Compartment Syndrome (WSACS) definitions and management guidelines relating to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS).
Summary Background Data: Updated guideline generation utilizing Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was conducted.
Methods: Existing definitions were reviewed. Quality of evidence (QoE) was judged from high (A) to very low (D) and strength of recommendations from strong RECOMMENDATIONS (desirable effects clearly outweighed potential undesirable ones) to weaker SUGGESTIONS (risks and benefits of intervention opposed to alternatives less clear) or NO RECOMMENDATIONS when clear uncertainty existed. All statements were reviewed by a Pediatric Sub-Committee.
Results: In addition to established Definitions, the panel defined the open abdomen (OA), polycompartment syndromes, abdominal compliance, and suggested an OA grading system. RECOMMENDATIONS concerned IAP measurement, avoidance of sustained IAH, efforts to achieve “same-hospital-stay” fascial closure, using protocolized monitoring and management, use of damage control techniques in overt ACS, and use of negative presure wound therapies to attempt earlier fascial closure among those with an OA. SUGGESTIONS included medical therapies and percutaneous drainage in IAH, considering body position, efforts to avoid positive fluid balances after initial resuscitation, use of enhanced ratios of plasma to red blood cells, use of prophylactic OA strategies in physiologicaly exhausted patients but not for intra-peritoneal contamination, and the avoidance of routine early biologic mesh use. NO RECOMMENDATIONS were possible regarding use of abdominal perfusion pressure, diuretics, or renal replacement therapies in hemodynamically stable patients with IAH.
Conclusion: Overall quality of available evidence was low which in conjunction with RECOMMENDATIONS emphasizing the urgent need for appropriately designed interventional trials among those with IAH and ACS.
6 Key Words: Intra-abdominal hypertension, abdominal compartment syndrome, critical care, Grades of Recommendation, Assessment, Development, and Evaluation Criteria, evidence-based medicine, World Society of the Abdominal Compartment Syndrome
7 Introduction
Owing to its restricted capacity to expand, the peritoneal cavity is subject to raised internal pressures like any other anatomic compartment. As pressure within this compartment increases above normal tissue perfusion pressure, the many critical viscera and vascular structures within may be compromised, initiating a cascade of events that may lead to organ dysfunction/failure and ultimately death if not corrected. Thus, raised intra-abdominal pressure (IAP), which constitutes intra-abdominal hypertension (IAH), has been increasingly recognized as being common and associated with pathology when sought. Detrimental physiologic associations with
IAH have been recognized in nearly all organ systems, including the cardiorespiratory, renal, neurologic, gastrointestinal, hepatic, and andrenocortical; related both to physical and humeral effects, ultimately manifested as the abdominal compartment syndrome (ACS) if overt organ failure ensues. Overt ACS is an end-stage manifestation of severe IAH, with a mortality approaching 100% without treatment in some reports. As ACS represents organ failure from
IAH, it may still be lethal even despite eventual decompression and correction of the underlying cause.
When first re-recognized in contemporary times, severe IAH/ACS was epidemic in severely ill/injured subgroups such as those with massive intra-abdominal hemmorhage requiring damage control who had their abdomens closed primarily. Secondary abdominal compartment syndrome was seen in many patients, such as those with massive burns or even extra-abdominal injuries in the setting of aggressive crystalloid resuscitation. In the ensuing period however, of not more than two decades since Kron’s sentinel description of the syndrome and its treatment, there has been an exponential growth in attention, research, and published material related to both IAH
8 and ACS. Specific milestones along this pathway have included the incorporation of the World
Society of the Abdominal Compartment Syndrome (WSACS - www.wsacs.org), it’s bi-annual scientific congresses, and a series of consensus guidelines relating to Definitions, Management, and Methods for Research produced by the WSACS. Concurrent major changes in the science and philosophy of the resuscitation and management of the critically injured/ill also include the wider application of damage control resuscitation for massive hemorrhage, early goal directed therapy for severe sepsis, and an appreciation of the general risks of over hydration, all appear to have impacted the epidemiology and impact of IAH/ACS in these populations. There have been also very significant paradigm shifts in the early delivery of care relating to both haemostatic and balanced resuscitation such that it has been suggested that damage control itself may be less important than previously emphasized. These changes are resulting in significant reductions in
ACS.
Thus, in light of these and other developments, the WSACS undertook a planned review and update of the Consensus Definitions and Management Guidelines to reflect recent advances in both clinical care and basic science. To provide consistency in rating the quality of the evidence and communicating the confidence of the clinical practice guidelines the WSACS chose to follow the principles of the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) system for clinical practice guidelines development.
9 Methods
Guidelines Committee Composition:
The 2013 Guidelines Committee (GC) of the WSACS consisted of a Chair, Coordinator, two
Methodological Advisors (impartial members of the GRADE Working Group), and several systematic review teams. Among the non-methodological advisor GC members, 8 were surgeons, who had subspecialty training in trauma and/or acute care surgery, general surgery, or vascular surgery, and 7 were experts in critical care medicine/anesthesiology or internal medicine, while 5 practiced both surgery and critical care medicine. The goal was to provide an updated “state-of-the-art” reference for IAH/ACS-related clinical and basic science research, remembering that the existing definitions have been previously been used to define IAH/ACS and related phenomena, wherein unnecessary changes would detract from the goal of diagnostic standardization and external validity.
Evaluation of Existing Expert Consensus Definitions:
The members reviewed, evaluated, and ultimately ratified the current 2013 expert consensus definitions through ongoing discussion and debate through electronic mail messages and posts upon a dedicated electronic Expert Consensus Definitions Billboard. In concordance with the levels of agreement appropriate for consensus, all expert consensus definitions for which more than 80% of the members voted to accept “as is” were retained, while all with less than 50% acceptance were rejected. Definitions with only 50-80% agreement were revised through ongoing discussions until complete consensus was obtained. Where extensive discussion among subspecialists or other experts was required, special sub-committees where created, including a
10 dedicated Pediatric Guidelines Sub-Committee who reviewed the adult guidelines regarding their generalizability to pediatrics and thereafter commented upon this when appropriate.
Development of Consensus Management Recommendations:
Use of GRADE and Development of Clinical Questions:
We followed the GRADE approach for guideline developers to generate management recommendations related to IAH/ACS from the patient perspective. Using this approach, GC members first defined specific clinical questions and patient-important outcomes with the assistance of two impartial methodological advisors and members of the GRADE Working
Group (R.J., G.H.G.). Questions were formulated according to the Patient, Intervention,
Comparator, and Outcome (PICO) format, and were based on polling of the WSACS Executive to redundancy (i.e., questions continued until no new clinical question themes or ideas could be identified). The final 12 clinical questions were perceived to reflect the most important management issues facing clinicians and/or those for which the evidence had evolved most rapidly since the 2006 WSACS guideline (Table 1). These identified clinical questions of interest were then later refined by the GC during a series of pre-meeting teleconferences with the assistance of the two methodological experts. The GC also reviewed the WSACS Management
Algorithm (Figure 1) in light of recent developments.
Systematic Reviews:
Systematic review teams subsequently conducted systematic or structured/semi-structured reviews and prepared evidence profiles for each of the identified patient-important outcomes as suggested by GRADE . As the details required to answer Management question were potentially
11 massive, each team was encouraged to prepare the detailed results as a stand-alone comprehensive review of that topic. To date the systematic review of negative-pressure would therapy (NPWT) comparative studies is the only one that has been individually prepared and published.
Grading of Evidence and Development of Consensus Management Recommendations:
After each systematic review team had conducted their search and created their initial evidence profile, formal face-to-face Expert Consensus Conference meetings for all GC members were held on two separate days immediately preceding and following the 5th Scientific Congress of the
WSACS in Orlando, FL, U.S.A on August 10th to 13th, 2011. At the Management Guidelines meeting, each systematic review team presented their search methods and evidence profile to the
GC and one of the methodological advisors (R.J.), whose role was to comment on their assessment of the quality of the available evidence. They then made recommendations to the
Panel regarding the direction (for/against/no recommendation), strength (recommend/suggest), and confidence (on an ordinal scale of 1 to 3) of the recommendation in accordance with
GRADE guidelines.
As recommended by GRADE, we first considered randomized controlled trials (RCTs) to represent high-quality evidence and observational studies as low-quality evidence, unless modified downward due to risk of bias, imprecision, inconsistency of results, indirectness of evidence, or publication bias or modified upward due to a large estimated magnitude of effect, evidence of a dose-response, or if confounders were likely to minimize the estimated magnitude of effect. Ultimately, the quality of evidence for each outcome was rated along a four-point
12 ordinal scale in which each evidence grade was symbolized by a letter from D to A: very low
(D), low (C), moderate (B), and high (A). Although principally designed for meta-analyses of
RCTs, summary of findings tables were created whenever possible using GRADEpro version 3.2 and the format used by the American College of Chest Physicians whenever feasible. These tables presented estimates of relative effect as relative risks (RR) with their 95% confidence intervals and anticipated absolute effects as mean differences with their associated 95% confidence intervals. As meta-analyses of randomized trials or high quality observational studies were frequently unavailable, these estimates were often derived from those reported by a single study or across a number of studies. All statistical analyses were conducted using Stata version
12.0 (Stata Corp., College Station, TX, USA).
Results
The following are concise results summarized from the Internal Report to the World Society of the Abdominal Compartment Syndrome from the Guidelines Committee on; Intra- abdominal hypertension and the Abdominal Compartment Syndrome: Updated
International Guidelines for Management from the World Society of the Abdominal
Compartment Syndrome
Consensus Definitions:
The final accepted consensus definitions of the WSACS are presented in Table 2. Overall, three of the original 12 definitions were accepted unanimously by the GC, and one was rejected by more than 50% of the GC. Thus, four were originally accepted by > 80% of the GC, and four
13 were accepted by greater than 50% of the GC, but required discussion to arrive at the presented definitions. The risk factors accepted in 2006 are shown in Figure 2. It was unanimously agreed that while understanding the risk factors for IAH or ACS were important, the listed factors were largely identified based on clinical intuition, acumen, and experience. Thus, dedicated sub-committees of the Guidelines Committee will conduct separate systematic reviews to produce evidence-based risk factors for IAH and to discern the most relevant location for zeroing baseline IAP measurements.
Changes or Additions to the 2006 Consensus Definitions:
Definition of the Open Abdomen:
The open abdomen continues to be variably defined, even in contemporary reviews, and surveys even among trauma surgeons reveals confusion as to exactly what anatomy constitutes an “open abdomen”. Surveys asking this simple question however have noted surprising confusion and disagreement in regards to skin closure without fascial closure, or visceral containment with mesh interposition between fascia with or without skin or soft-tissue closure.
The WSACS DEFINED an open abdomen as that requiring a temporary abdominal closure due to the skin and fascia not being closed after laparotomy. In order to facilitate research in this controversial field, the technical details regarding the type of temporary closure should be explicitly stated.
14 Lateralization of the Abdominal Musculature:
There are many recognized complications of the open abdomen such as entero-atmospheric fistulae; heat, fluid, and protein losses; catabolism; and increased nursing resources; among many others. However, loss of domain, wherein the peritoneal contents no longer reside naturally within the confines of the abdominal wall, may be an overlooked concern. Although not well studied or reported, this phonomenon is increasingly being understood as both influencing the degree of complexity involved in abdominal wall reconstruction, and as an undesireable outcome that temporay abdominal closures aim to avoid.
To assist in understanding this area, the WSACS DEFINED lateralization of the abdominal wall to refer to the phenomenon whereby the musculature of the abdominal wall, most examplified by the rectus abdominus muscles, moves lateraly away from the midine with time and the pericolic gutters become obliterated.
Classification of the Open Abdomen:
Planning to successfully and safely close any open abdomen must begin immediately after the abdomen is first left open. It is critical that when studies are conducted that they address abdominal closure rates considering the indications for open abdominal management, differing comparators, and that abdominal-closure problems of similar difficulty are compared. Thus a classification scheme of open abdomen complexity is required. Two schemes have been previously proposed, that of Swan and that of Bjorck. The WSACS recognizes two critical
15 complications which should be considered in managing an open abdomen; namely fixation of the abdominal contents especially of the viscera to the side-walls, and the development of an enteroatmospheric fistula (EAF). The classification of Bjork was therefore amended to reflect this hierarchy of challenges to the patient (Table 3).
Abdominal Compliance
The abdominal compliance quantifies the ease of abdominal expansion and is determined by the elasticity of the anterior and lateral abdominal wall and to a smaller degree the diaphragm, whereas the more rigid spine and pelvis only minimally if at all affect abdominal elasticity. The abdominal compliance changes with changes in abdominal volume. It can be expressed as the slope on a volume-pressure curve and the slope will depend on its position on the abdominal volume-pressure curve. At normal physiological conditions with normal abdominal volumes an additional predefined abdominal volume will only minimally increase IAP. However, when the abdominal volume is already increased as in high grade IAH, the same abdominal volume will significantly increase IAP. A reduced abdominal compliance implies that any change in volume increase will result in a greater change in IAP, as found in patients with abdominal burn eschar, tight closure following abdominal surgery, or generally in those with high grade of IAH. A compliant abdomen, however, indicates greater tolerance to changes in intra-abdominal volume as seen in the elderly patient with loss of elastic recoil of the abdominal wall, women after childbirth, or in the obese after weight loss. Abdominal compliance should be expressed in
L/mmHg.
16 The WSACS DEFINES “abdominal compliance” as a measure of the ease of abdominal expansion, and is determined by the elasticity of the abdominal wall and diaphragm and is expressed as a change in intra-abdominal volume per change in intra-abdominal pressure.
Pediatric Guidelines Sub-Committee
Akin to the adult situation, the influences of IAH and the occurrence of ACS is being more commonly reported in children. While the original, and now these revised WSACS guidelines may serve as guides for many conditions, they cannot be applied directly to all children. The
Pediatrics Sub-Committee reviewed these guidelines derived from adult care and considered their applicability for use in Pediatrics. The Sub-Committee accepted 10 of the adult definitions as appropriate for Pediatric use, rejected 4 as inappropriate, and was unable to make a recommendation regarding appropriateness regarding the threshold levels of IAH grades (not to be confused with the GRADE methodology). The sub-committee also reviewed relevant pediatric studies to arrive at the accepted and proposed pediatric definitions.
A summary of the final accepted Pediatric Definitions is presented in Table 4. For the four definitions rejected, new Definitions, specific for Pediatric use were proposed. As the threshold cut-off of 20 mmHg may be too high in certain patients and as APP thresholds of 60mmHg were definitely considered too high, the Pediatric Sub-Committee of the WSACS DEFINES ACS in children as a sustained elevation in IAP of greater than 10mmHg associated with new or worsening organ dysfunction that can be attributed to elevated IAP. Several studies have demonstrated that over-distending the bladder with a priming volume of fluid may lead to
17 erroneous readings. This was the reason behind reducing the recommended priming volume in adults. A prospective study involved 96 pediatric patients in whom intra-abdominal pressure - bladder volume curves were generated, minimum optimal volumes of 3mL for bladder instillations were determined for children. This study also determined normal IAP in critically ill children to be 7±3 mmHg. Thus, the Pediatric Sub-Committee of the WSACS DEFINES the reference standard for intermittent IAP measurement in children as being via the bladder using 1 ml/kg with a minimal instillation volume of 3ml and a maximum instillation volume of 25ml of sterile saline. The Pediatric Sub-Committee of the WSACS further DEFINES
Normal IAP in critically ill children as being approximately 4 – 10 mmHg and DEFINES
IAH in children as being a sustained or repeated pathological elevation in IAP > 10mmHg.
Although the data is limited in quality, it is well known the all physiologic pressures are generally lower in children than in adults, including IAP, even during critical illness.
Consensus Management Statements
While Table 5 affords an overview of the structured clinical questions, Consensus Management
Statements are summarized in Table 6. Following is an overview of the background (narrative), evidence summary, and rationale associated with each statement, using the presentation structure previously employed by the American College of Chest Physicians.
Management Question 1) Should we measure intra-abdominal pressure?
Narrative:
18 As clinical examination is an inaccurate predictor of IAH, research and quality assurance on IAH and ACS relies upon the accurate measurement of IAP . Although there is an increasing number of IAP measurement techniques and equipment, trans-bladder measurement techniques remain a commonly used method.
Evidence Summary:
Systematic review revealed only one RCT that compared the outcomes of IAP management among those with severe acute pancreatitis with a control group of the same patients who did not receive IAP management . While those in the measurement/management group had a lower risk of mortality and a reduced length of hospital stay, the quality of evidence afforded by this study was very low due to risk of bias, indirectness, and imprecision. There were also six cohorts of critically ill patients in which the introduction of either a protocol encompassing IAP measurement, or interventions triggered by IAP measurements were studied before and after the introduction of these measures, all with apparent benefit. However, these studies enrolled varied populations of critically ill adults with diagnoses that included decompensated heart failure, burns, or pancreatitis, and examined a number of medical or surgical interventions, making it difficult to determine whether improved IAP or the intervention resulted in the observed outcomes. Thus, they are also limited by risk of bias, indirectness, and imprecision.
Recommendation
The WSACS RECOMMENDED measuring intra-abdominal pressure versus not measuring when any known risk factor is present in a critically ill/injured patient
19 (Management Recommendation 1; [GRADE 1C]. The panelists also RECOMMENDED that studies in this area adopt the current standard IAP measurement technique
(Management Recommendation 2; [not GRADED]), Finally, the panellists also
RECOMMENDED use of a protocolized monitoring and management of intra-abdominal pressure versus not (Management Recommendation 3; [GRADE 1C).
Rationale for Reccomendation
The ease of measurement of IAP through a bladder catheter significantly influenced our
Recommendation as the perceived side-effects were minimal and the information obtained has the potential to greatly influence individual patient care. It was acknowledged that these were high level recommendations, largely based on the perceived value to patients and the resource implications.
Management Question 2): How should we interpret IAP?; The abdominal perfusion pressure (APP):
Narrative
APP, which may be thought of as an intra-abdominal analogue to cerebral perfusion pressure, is defined as mean arterial presure (MAP) minus IAP. This measure has previously been suggested to be a more accurate predictor of visceral perfusion and a better endpoint for resuscitation than
IAP or MAP alone .
20 Evidence Summary (Table 8):
Systematic review revealed no relevant APP management RCTs or meta-analyses. However, among 12 observational studies of patients with IAH or ACS, the majority suggested that a reduced APP may be a poor prognostic factor among critically ill patients . Many of these studies enrolled different populations of ICU patients and were of lower quality due to risk of bias and indirectness.
Reccomendation
The WSACS could make NO RECCOMENDATION regarding the use of the APP in the resuscitation/management of the critically ill/injured.
Rationale for Recommendation:
The major limitation of all the available studies is their observational design. Although reduced
APP may be a poor prognostic factor among those with IAH, it remains unclear if improving or increasing APP results in improved outcomes.We therefore conclude that the quality of evidence is very low (Grade D). Future interventional trials are required using APP as a resuscitation endpoint compared to the more commonly used parameters.
Management Question 3) Should we treat IAH?
Narrative:
21 The occurrence of IAH, and especially overt ACS, has been well documented in multiple settings in multiple countries to associate with morbidty and mortality, but it remains uncertain as to whether treating or preventing these conditions improves outcomes.
Evidence Summary
We found no RCTs or meta-analyses that provided specific data relevant to this question. There were no controlled trials that utilized comprehensive management strategies to defend against any particular level of IAH compared to another or no management. Therefore a summary of findings table cannot be presented. The only available data derives from a single prospective cohort study that compared the outcomes of 478 consecutive OA patients who were managed using the 2006 WSACS definitions and an a priori evidence-based management algorithm. As compared to historical controls managed according to present standards of care, IAH and ACS management was significantly associated with increased survival to hospital discharge and decreased resource utilization . In addition, Ivatury noted IAP levels commensurate with ACS in 52% of patients whose fascia was primarily closed versus of 22% of those with an absorbable mesh closure after damage control surgery. Further low quality evidence is also available .
Recommendation
The WSACS RECOMMENDS efforts and/or protocols be utilized to avoid sustained IAH, versus inattention to the IAP in critically ill patients (Management Recommendation 4;
GRADE 1C).
Rationale for Reccomendation
22 After reviewing the evidence, the WSACS panel initially suggested that efforts and/or protocols be utilized to maintain IAP less than 20 mmHg. After deliberation, the recommendation was reworded to state that the focus should be on preventing IAH in general, rather than focusing on any one arbitary level of IAP. The QofE rating was influenced by the large size and inherent biological rationale of the observational study.
Management Question 4) How should we treat intra-abdominal hypertension?
Overview:
In addition to decompressive laparotomy for ACS, numerous less invasive therapies have been proposed or studied that may improve patient-important outcomes among those with IAH or
ACS . A best practice protocol guideline was promulgated by the WSACS in 2007 (Figure 1) and was critically reexamined.
Non-Invasive Options
Previous approaches or techniques of potential utility for improving outcomes among those with
IAH or ACS that were previously addressed in the orginal WSACS guideline included sedation and analgesia, neuromuscular blockade, body positioning, nasogastric/colonic decompression, promotility agents, diuretics and continuous renal replacement therapies, different fluid resuscitation strategies, percutaneous drainage, and abdominal closure techniques. Each of these component therapies was readdressed by the GC in addition to the major 12 management questions.
23 Sedation and analgesia
Narrative:
While sedation and analgesia form part of the care plan of the critically ill/injured, and have been incorporated within previous management algorithms, there remains minimal prospective data regarding their effects on outcomes among those with IAH.
Evidence Summary:
The evidence for sedation and analgesia among those with IAH or ACS is very limited.
Although this finding has not been replicated in large animal models, fentanyl has been shown to cause large increases in abdominal pressure through stimulation of active phasic expiratory activity .
Recommendation:
In the absence of robust data, the WSACS continues to SUGGEST (GRADE 2D) that clinicians strive to ensure that the critically ill/injured receive optimal pain and anxiety relief as part of overall critical care (Management Suggestion 1.
Rationale:
Although sedative agents may improve IAH through a reduction in agitation in critically ill patients, it should be recognized that strategies that attempt to limit sedation among the critically ill have been associated with improved outcomes in numerous RCTs.
24 Neuromuscular blockade: Narrative
Through a reduction in abdominal muscular tone and an increase in abdominal compliance, neuromuscular blockade may reduce IAP among those with IAH or ACS.
Evidence Summary:
A single prospective report demonstrated that the non-depolarizing neuromuscular blocking agent cisatracurium decreased IAH temporarily, with rare patients failing to respond. A retrospective non-randomized review among OA patients administered NMB noted faster and more frequent attainment of primary fascial closure by day 7. This modest experience corroborates that of case reports, and a small series of non-traumatic brain injuries.
Recommendation
Thus the WSACS continues to SUGGEST (GRADE 2D) brief trials of neuromuscular blockade as a temporizing measure in the treatment of IAH (Management Suggestion 2).
Rationale
This intervention is only suggested given the potential benefits that may occur by avoiding other more invasive interventions. However, the confidence in this recommendation is low.
Body Positioning: Narrative:
Body positioing may greatly affect the measured IAP by changing the zero reference, physical changes in the actual IAP, or both.
25 Evidence Summary
Critically ill patients should generally be maintained in a head-up position to reduce the risk of aspiration and nosocomial pneumonia. However, raising the torso upwards from the supine position can increase IAP by up to 2 grades of IAH. Likewise, prone positioning has been reported to increase the relative IAP, but is dependant on the method of proning and on abdominal compliance.
Recommendation:
The WSACS SUGGESTS that the potential contribution of body position in elevating IAP should be considered in patients with moderate to severe IAH or ACS (GRADE 2D)
(Management suggestion number 3).
Rationale:
The WSACS previously recognized the potential contribution of body position to IAP elevation in patients with moderate to severe IAH or ACS. However, body positioning has never been studied in relation to patient-important outcomes and therefore will be the focus of attention of a dedicated committee for future consensus.
Nasogastric/colonic decompression: Narrative:
While the routine use of enteric tubes post-operatively is not associated with benefit after uncomplicated surgery, there are anecdotal reports that both gastric and colonic distension can induce marked IAH to the point that organ failure commensurate with the ACS occurs as well as supporting animal models.
26 Evidence Summary:
The evidence is low and indirect, with marked IAP increases after gastroscopy in animals noting correlated with respiratory compromise, and the increased IAP from colonoscopy significantly increasing intracranial pressure (ICP), akin to porcine models in which raised IAP is reflected in raised ICP.
Recommendation
The WSACS SUGGESTS liberal use of enteral decompression with naso-gastric or rectal tubes when the stomach or colon are dilated in the presence of IAH/ACS (GRADE 1D).
Rationale:
No relevant studies of the effect of nasogastric/colonic decompression on outcomes yet exist among critically ill human populations. Nontheless, based on the relative ease and safety
(especially in comparison to other invasive interventions designed to decrease IAP), it may be considered as a therapeutic option.
Promotility agents: Narrative and Evidence Profile:
There is no good data studying the effects of pharmacologic pro-motility therapy to decrease IAP or to treat established IAH/ACS. However, if colonic dilation occurs to the point of acute colonic pseudo-obstruction, pharmacologic treatment with neostigmine was shown to be effective at inducing colonic decompression in a small non-blinded series. There is evidence from an RCT that epidural neostigmine shortens the period of post-operative ileus after open
27 abdominal aortic surgery, as well as many novel prokinetics that have promise but require further study.
Recommendation
The WSACS SUGGESTS that neostigmine may be used for the treatment of establised colonic ileus not responding to other simple measures and inducing IAH (GRADE 2D) although other agents and settings require further study before recommendations can be made.
Rationale:
This data may however indirectly applied to the issue of IAH/ACS at best.
Fluid Management Strategies: Overview
Administering fluids to the critically ill/injured has long been a basic initial response among clinicians world-wide. This is potentially justified by the fact that the shock state necessitates an obligatory loss of fluid to the “third space”, and this has saved numerous lives and significantly reduced the risk of renal failure as a complication of burn injury. However it has been frequently observed that excessive resuscitation with crystalloid fluids may be contribute to an increased incidence of ACS. Indeed, positive fluid balance resulting from third spacing is independently associated with impaired organ function and worse outcome. Conversely, achievement of negative fluid balance restrospectively predicts survival associates with improved lung function.
Thus, the overall topic of fluid management strategies was considered as an overarching concept, followed by individual considerations of the types of fluids, and thereafter potential modalities to modify body fluid’s such as diuertic therapy and renal replacement therapies.
28 Fluid Therapy:
Narrative
This question was formulated as: does a management strategy attempting to obtain fluid balance in equilibrium or even negative (conservative fluid strategy) after day 3 result in a lower IAP and improved patients outcomes compared to management strategies that either accept a liberal fluid management and will the latter result in higher IAPs in critically ill adults in critical care units?
Evidence Summary
Systematic review identified 40 relevant citations, including one meta-analysis (published in abstract form), 10 RCTs, 7 interventional studies, 28 observational studies, and 4 case series, which examined a total of 23625 critically ill patients. In 23 studies, IAP was measured. A
Summary of Studies is available at (http://www.traumacanada.org/Default.aspx?pageId=829763).
Fluid balance and survivorship
A meta-analytic aproach was utilized analyzing the best available data abstracted from 7 uncontrolled prospective cohort studies, 2 uncontrolled retrospective cohort studies, 2 retrospective non-randomized controlled cohort studies, and a retrospective review of a randomized trial of a separate intervention that considered fluid balance in relation to survival in critical illness. When compiled, the data from a total of 3246 patients enrolled in these 13 studies revealed that non-survivorship (n= 1643, mortality being 50.6%) was asociated with a more positive cumulative fluid balance by day 7 of their ICU stay. The cumulative FB was on
29 average 4628 ml more positive in non-survivors compared to survivors. The collated findings of these studies is presented at (http://www.traumacanada.ca/media/Abd_compartment/Fluid
%20balance%20and%20survivorship%20for%20TAC%20website.pdf)
Management approach to fluid management and mortality: Does outcome asociate with reduced fluid balance.
The compiled data from 12871 patients enrolled in 23 studies involving critically ill and peri- operative patients showed that outcome was significantly improved when associated with a conservative fluid regimen (OR 0.34). This is illustrated in the Forest plot at
(http://www.traumacanada.ca/media/Abd_compartment/Forest%20plot%20looking%20at%20the
%20effect%20of%20a%20restrictive%20fluid%20regimen%20on%20mortality.pdf). In patients treated with a restrictive fluid regimen the associated mortality decreased from 29.1% (1859 deaths in
6384 patients) to 22.2% (1443 deaths in 6488 patients)(p<0.0001). Actual data on cumulative
FB was available in 6555 patients from 13 studies: overall conservative treatment was associated with a less positive FB and the cumulative FB was on average 5470 ml less positive after 1 week of ICU stay. The summary of findings of these studies and Forrest plots are given at
(http://www.traumacanada.ca/media/Abd_compartment/Cumulative%20Fluid%20Balance%20after
%201st%20ICU%20Week.pdf).
Do patients with IAH have a more positive fluid balance?
Data was available from 1517 patients recovered from 8 cohort or case-controlled studies. Meta- analyzing the pooled results revealed that the 597 patients with IAH (incidence being 39.4%) had a more positive fluid balance than those without IAH. The cumulative FB after 1 week of ICU
30 stay was on average 3389 ml more positive. The summary of findings and Forrest plots are given at (http://www.traumacanada.ca/media/Abd_compartment/Cumulative%20fluid%20balance%20and
%20intra-abdominal%20hypertension.pdf).
Does IAP improve with interventions acting on lowering FB?
Only 10 studies looked at the effects of net fluid removal strategies (use of furosemide or renal replacement therapy with net ultrafiltration) on IAP. These were case studies or small series. An overall total fluid removal of 6810 ml was associated with a drecrease in IAP from 21.5 to 12 mmHg. A dose related effect was observed: the more negative the fluid balance the greater the decrease in IAP.
Recommendation
The WSACS SUGGESTS using a protocol to try to avoid a positive cumulative fluid balance in the critically ill with, or at risk of IAH, after the acute resuscitation has been completed and the inciting issues/source control have been addressed (Management
Suggestion Recommendation 4; GRADE 2C).
Rationale
Consistently in critical care, patients who can be cared for without requiring massive fluid administration have better outcomes. The overall evidence to date eflects association rather than causality however and much of the outcome data was surrogate in nature. On a practical basis at the bedside, this may be interpretted as atempting to obtain a zero to negative FB by day 3 in
31 those who have been resuscitated to hemodynamic stability and to keep the cumulative FB on day 7 as low as possible.
Diuretics:
Narrative
Diuretics are used frequently if not routinely to attempt to improve fluid balance.
Evidence Summary and Rationale:
There were no RCTs or meta-analyses of diuresis among critically ill patients with IAH or ACS.
Reccomendation:
The WSACS makes NO RECOMMENDATION regarding the use of diuretics versus nothing to mobilize fluids in hemodynamically stable patients with IAH after the acute resuscitation has been completed and the inciting issues/source control have been addressed.
Rationale:
The lack of evidence to support this intervention results in uncertainity regarding it’s role in managing IAH, and thus need for further study.:
Renal replacenment therapies:
32 Narrative
Renal replacement therapies are increasingly being used to modify fluid balance among the critically ill.
Evidence Summary and Rationale
There were no relevant RCTs or meta-analyses to guide recommendations. There has been some uncontrolled and small studies without treatment comparitors that demonstrate reductions in IAP after therapy however. There is also some suggestions that dialysis therapies may target the inciting biomediators of inflammation. The remaing evidence is of case reports only.
Recommendation
The WSACS makes NO RECOMMENDATION regarding the use of RRT’s versus none, to mobilize fluids in hemodynamically stable patients with IAH after the acute resuscitation has been completed and the inciting issues/source control have been addressed.
Rationale
The lack of consensus for this intervention, underscores the uncertainity regarding it’s role in managing IAH, and the need for further study.
Albumin:
Narrative
Albumin is frequently administered as both a plasma expander and means of increasing plasma oncotic pressure in the critically ill.
33 Evidence Summary and Rationale
Despite well performed efforts to examine the role of albumin as an example of a colloid fluid in critical care, the randomized trials conducted to date have not specifically examined outcomes among those with IAH or ACS.
Reccomendation
The WSACS makes NO RECOMMENDATION regarding the adminstration of albumin versus not, to mobilize fluids in hemodynamically stable patients with IAH after the acute resuscitation has been completed and the inciting issues/source control have been addressed.
Rationale:
The lack of consensus for this intervention, underscores the uncertainity regarding it’s role in managing IAH, and the need for further study.
Damage control resuscitation (DCR) strategies:
Narrative
One of the most frequently discussed potential advances in contemporary trauma care is the concept of “DCR”. DCR involves utilization of permissive hypotension, limiting crystaloid fluids, and delivering higher ratios of plasma and platelets to red cells than has typically been used. Despite concerns regarding the methodology of supporting studies and the purported
34 mechanisms of DCR in enhancing survival, the approach at minimum moderates crystaloid over- resuscitation.
Evidence Summary:
A recent systematic review recovered 11 observational (three prospective, seven retrospective studies and one historical case-control) study that addressed the early and aggressive treatment of trauma-associated coagulopathy through transfusion of high plasma to packed red blood cell ratios. A summary of studies is presented at (http://www.traumacanada.org/Default.aspx?
pageId=829763 . Only two of these reports(23, 24) considered the issue of IAH/ACS. In a single-institution review of 390 patients undergoing “damage control laparotomy”, there were
108 patients treated with a high ratio of plasma, and 282 were historical controls with the groups receiving on average 13 versus 7 units of PRBCs, and significantly less crystalloid fluids in the treatment group. The peak IAPs were reported to be “lower in the DCR group” although these details are not expicitly reported. The same author however, subsequently reported a detailed series from another institution comparing a high ratio of plasma and platelets to PRBCs resuscitation protocol to historical controls and noted decreases in the reported rates of; the ACS from 10 to 0%, of open abdomens from 30 to 6%, and halving of the rate of multi-system organ failure associated with greatly reduced crystalloid infusion, although detailed data on IAP was not reported.
Reccomendation
The WSACS SUGGESTS that an enhanced ratio of plasma/RBCs strategy should be considered in massive hemorrhage versus low or no attention to plasma ratios
(Management suggestion 5; GRADE 2D).
35 Rationale
Although DCR seems to avoid massive crystalloid over-resuscitation and possibly IAH/ACS, its impact on patient-important outcomes remain unknown. Appropriately designed RCTs are therefore urgently needed.
How should we treat intra-abdominal hypertension? Minimally-invasive options:
Narrative
If the medical management approaches suggested above do not alleviate IAH, then clinicians will need to consider invasive approaches which may be increasingly invasive.
Percutaneous catheter drainage (PCD):
Narrative
Although paracentesis has long been a diagnostic and therapeutic procedure, the insertion of an indwelling PCD catheter in an attempt to improve IAP and associated patient-important outcomes among those with IAH/ACS was first suggested in 2001, and has since been increasingly investigated as a minimally-invasive treatment.
Evidence Summary (Table 9):
A single RCT compared PCD to control therapy among adults with severe acute pancreatitis reported a non-significant improvement in mortality and a significantly reduced length of hospitalization with PCD . Evidence from this trial is of very low quality because of a very serious risk of bias as well as indirectness and imprecision. A second severity of illness-matched
36 cohort study compared PCD with open abdominal decompression and reported that PCD was similarly effective at reducing IAP and improving APP, although they were unable to demonstrate a survival or duration of hospitalization benefit for PCD . Finally, three before-and- after case series reported that PCD was variably effective at improving IAP or other surrogate measures among those with drainable intraperitoneal fluid. The GRADE Pro Table is presented in Table .
Recommendation:
The WSACS SUGGESTS the use of PCD to remove fluid (with obvious intra-peritoneal fluid) in those with IAH/ACS when this is technically possible compared to doing nothing
(Management Suggestion 6; GRADE 2C). Alternatively, the WSACS also SUGGESTS that
PCD be used to remove fluid (with obvious intra-peritoneal fluid) in those with IAH/ACS when this is technically possible compared to immediate decompressive laparotomy, as this may alleviate the need for DCL (Management Suggestion 6; GRADE 2D).
Rationale:
The comparator for PCD [doing nothing (i.e. usual care) or a decompressive laparotomy, both of which are linked with significant morbidity and mortality] had a major impact on the development of a recommendation. Although the the panel recognized that the quality of evidence supporting PCD was low, and that high-quality randomized trials are needed, they felt that it had not been linked with significant complications. Thus, PCD may be a viable management strategy among those patients with sufficient free intraperitoneal fluid or blood to permit safe catheter placement.
37 How should we treat intra-abdominal hypertension? Surgical decompression for abdominal compartment syndrome:
Narrative
Formal surgical abdominal decompresive laparotomy performed through a midline laparotomy constitutes the standard method to treat severe IAH/ACS, as well as to prophylaxis against the occurrence of these entities in high risk situations. While minimally and less invasive surgical options are being investigated, formal laparotomy remains the standard of comparison. It may be life saving in cases of overt ACS, with immediate decreases in IAP and frequent improvements in organ function occuring. However, decompressive laparotomy is associated with multiple potential complications and overall reported mortality is considerable (up to 50%) even after decompression.
Evidence Summary
No RCTs compared DCL to strategies not using DCL in critically ill adults and there were no meta-analyses. The best available data consisted of 16 before-and-after case series. The
Summary of studies is presented at (http://www.traumacanada.org/Default.aspx?pageId=829763).
The effects of DCL were investigated in several series including > 350 patients with IAH or
ACS due to different causes. Most of the studies were retrospective; in three studies, data were collected prospectively. The disease acuity was poorly described, with APACHE II score reported most frequently, and ranging from 20-30. The IAP at which DCL was decided or performed varied widely, with mean IAP levels before DCL reported in adults studies between
21 and 49mmHg, and lower levels in pediatric patients. Overall, with the patient serving as its own control, IAP was lower after DCL in the studies that reported on IAP before and after DCL.
38 When expressed as percentage change from baseline, the effect of DCL was the highest when baseline IAP was high. The PaO2/FiO2 ratio was reported most frequently, and – when reported - found to be higher in all studies, although the difference was not always statistically significant.
Other effects on organ function included a decreased vasopressor need, increased oxygenation index, decreased lactate levels, decreased SOFA score, and increased static compliance. We consider these outcomes as indirect in relation to important patient outcomes of mortality.
Recommendation
After discussion the WSACS RECCOMENDS the use of DCL to reduce IAP in cases of overt ACS compared to strategies that do not use decompressive laparotomy in critically ill adults with ACS in critical care units (Management Recommendation 5; GRADE 1D).
Rationale:
These studies were limited by a high risk of bias and inconsistency in their effect on IAP as a surrogate outcome. Moreover, no study was able to examine the effect of decompressive laparotomy on patient-important outcomes. Therefore , the WSACS judged the overall quality of evidence describing the effect of decompressive laparotomy in patient important outcome as very low (D), but yet the dramatic and profound reversal in physiology that DCL may engender immediately upon release of overt ACS is apparent to most practising acute care/trauma surgeons.
Traumatic injury and damage control surgery:
Narrative
39 The “damage control” (DC) approach to managing severe trauma involves an abbreviated resuscitative surgical approach with the primary goal being rapid control of hemorrhage and contamination with the goal of restoring metabolic function at the expense of normal anatomy.
Damage control surgery typically is a component of a larger DC approach to the totality of a massive traumatic insult. Although it remains difficult to prove that this approach improves mortality and other outcomes, it has been credited with many unexpected survivals. In this approach, high indices of suspision are necessary, including the admonition to leave the abdomen open both to expediate the procedure and to prophylax against severe IAH/ACS post- injury. This does introduce numerous other potential complications of the OA, and it has been potentially overused for patients without traditional indications for damage control.
Evidence Summary
No prospective studies were identified that specifically addressed the question. In no related studies available was the routine of IAP measurements described, nor was the incidence of IAH assessed. The most related evidence was inferential. One trauma registry based analysis reported the reduction of ACS from 10% to 0% after the implementation of Trauma
Exsanguination Protocol in a Level I trauma center. A second registry analysis reported IAP to be “lower in the DCR group” without explicit details(23). Data related to the administration of enhanced ratios of FFP/PRBC indirectly relates to the larger domain of DC, and has been the subject of one systematic review and 11 retrospective trials, although no RCTs (4). However, no specific attention has been given to the issue of IAH/ACS.
Reccomendation:
40 The WSACS SUGGESTS that patients undergoing laparotomy for trauma suffering from physiologic exhaustion be treated with the prophylactic use of the OA versus closure and expectant IAP management (Management suggestion 7; GRADE 2D).
Rationale
The utilization of newer resuscitation practices (such as DCR) that obviate the need for DC surgery, may be in the interest of the patient. However, until this is clearly established, those patients who are approriately selected as requiring DC are at high risks of developing post- operative ACS if the abdomen is formally closed and expected IAP management selected.
Non trauma acute surgery: Narrative
While DC approaches have been considered in numerous other critical settings besides trauma, such as acute surgery, the experience and numbers of patients so treated are fewer.
Evidence Summary:
There were no relevant RCTs and thus no meta-analyses. While reported, the use of the open abdomen in non trauma acute surgery has been more a proof of concept rather than providing comparative experience. Reports specifically using an open abdomen include an uncontrolled case series reporting the feasbility in acute surgical cases, cases reports. Other evidence is even more indirect, reflecting the combined use of Damage control, which presumably includes OA techniques.
Recommendation:
41 The WSACS could make NO RECOMMENDATION regarding the prophylactic use of the OA in emergency surgery patients with physiological exhaustion versus closing and expectant IAP management.
Rationale:
Given that shock from almost any cause that elicits aggressive massive crystalloid fluid resuscitation on the part of the caregivers may precipitate either primary or secondary IAH/ACS, this lack of recommendation reflects a current lack of evidence rather than a validation of current practice.
Intra-abdominal Sepsis:
Narrative
Intra-abdominal sepsis (IAS) is a particularly devastating and commonplace form of sepsis that may be expected to demonstrate IAH/ACS both from the disease (primary IAH/ACS) and the therapy (secondary IAH/ACS).
Evidence Summary:
Previous attempts to ameliorate this risk by routinely employing an open abdomen solely to facilitate future routine “wash-outs” however, have not proved beneficial in some cohorts and analyses, and have resulted in greater costs across different subgroups and disease courses in others.
Reccomendation:
42 The WSACS SUGGESTS NOT utilizing the routine use of the open abdomen for those patients with severe intra-peritoneal contamination undergoing laparotomy for emergency surgery
(Management Suggestion 8; GRADE 1B).
Rationale:
While IAP surveillance is required, prophylactic OA is not mandated in this setting.
Definitive Abdominal Closure
While the open abdomen is a valuable, life-saving tool, the longer the abdomen is open, the greater is the potential morbidity. Thus, specific strategies should be utilized from the first laparotomy that consider the prevention of visceral adhesions, loss of soft tissue coverage, lateralization of the musculature, malnutrition, and especially enteric fistulae. There are real concerns that the shifting pendulum of of clinical practice has over-utilzed this technique in cases without traditional indications. The detailed management of the open abdomen is beyond even the scope of this document. It should thus be clearly understood that the WSACS positions are selected from within this broader topic, for which other recent reviews are available.
Same hospital stay closure of the Open Abdomen: Narrative
The question was formulated as “Does the use of a management strategy involving efforts at closing the fascia of an OA improve patient outcomes compared to strategies that do not use
43 stratregies to close the fascia and that thus accept skin grafts and delayed reconstruction in critically ill adults in critical care units.
Evidence Summary
There were no well performed RCTs nor observational studies, evaluating different treatment strategies in how to prevent complications and achieve early closure of the open abdomen. The only direct RCT ever conduced was underpowered, had mixed treatment groups, used gastrostomies and jejunostomies (increasing risk of EAF), and therfore suffered from risk of bias. Systematic reviews of the litterature compared different TACs, regarding complications and closure rates. In these reviews closure rates were higher after Vacuum Pac (Brook, Barker) or VAC) than after simple mesh/cover of the Bogotá type, but numbers were too small, and patients to heterogeneous, to be able to compare complication rates. Recently, even higher rates of early closure of OAs have been reported with combined vacuum and mesh-mediated fascial traction in nob-randomized cohorts.
Reccomendation:
The WSACS RECOMMENDS that in patients in critical care units conscious and/or protocolized efforts be made to obtain an early or at least “same hospital stay” closure
(GRADE 1D; Management Statement).
Rationale:
From a patient and societal perspective, same hospital closure, if it can safely be avoids the need for future complex care and is very desireable. While protocolized care in general improves patient outcomes across a wide variety of settings, what techniques or specific efforts that in
44 particular that should comprise such strategies or protocols are controversial and remain difficult questions. Thus a future planned endeavour is to examine the data and provide consensus guidelines regarding the specific recommended techniques to achieve these goals.
Negative Pressure Wound Therapy: Narrative
Negative pressure wound therapy (NPWT) involves applying some degree of suction to an open wound, using techniques that can be home-made or proprietary. Through use of a visceral drape and other means, this technique prevents visceral adherence to the anterolateral abdominal wall while maintaining medial fascial traction, which may enhance fascial closure rates. It may also remove pro-inflammatory cytokines from the peritoneum, which may reduce the systemic inflammatory response and resultant organ dysfunction. However, others have reported concerns over associations with recurrent ACS or intestinal and enteroatmospheric fistulae.
Evidence Summary and Rationale (Tables 10 and 11):
Systematic review identified three systematic reviews (two of which performed a weighted pooled outcomes analysis or meta-analysis whereas the third did not due to concerns about clinical and methodological heterogeneity), two randomized trials, and nine cohort studies (three prospective/six retrospective). Two systematic reviews were available, but both those had moderate methodologic concerns. Although negative pressure wound therapy was associated with several improved surrogate and clinical outcomes among critically ill adults with open abdominal wounds (which are presented in order to estimate effect size), these studies suffered from a significant risk of bias. In addition to enrolling small sample sizes, only one of the identified RCTs described allocation concealment, and inadequate masking of allocation can
45 significantly alter effect estimates. Moreover, although the estimates presented in the summary of findings table are based on best available evidence, these are very indirect as they often involved comparisons between case series of patients managed with different temporary abdominal closure techniques and across a range of time periods. Moreover, most studies afforded little data on indication for open abdominal management or injury/illness severity was available, making it unclear if the comparisons across studies were fair or appropriately balanced.
Recommendation:
The WSACS RECOMMENDS that in critically ill/injured patients with open abdomens strategies utilizing negative pressure wound therapy should be used versus not
(Management Recommendation 6; GRADE 1C).
Component Separation: Narrative
The component separation technique (CST) of the abdominal wall musculature, 228, 243), has become a frequently used method of abdominal wall closure, being performed completely open, semi-open, or laparoscopically. CST is becoming integral to IAH management in increasing intra-peritoneal domain and may be required to close an already open abdomen, or to even avoid an OA without inducing IAH. An acute CST is defined as one performed during the initial hospitalization .
Evidence Summary and Rationale:
46 The evidence however, concerning the use of CST in relation to critically ill adults with IAH is extremely limited, with no MA’s, RCTs, or cohort studies other than case series. The Summary of Studies is presented at (http://www.traumacanada.org/Default.aspx?pageId=829763).
Reccomendation:
The WSACS could make NO RECOMMENDATION relating to the use of CST to facilitate early fascial closure versus not.
Rationale:
Although the quality of evidence is very low, the CST is intuitively and potentially beneficial in being able to safely close the OA earlier and yet still obtain medialization of the recti. However, the CST can only be utilized once, and early use precludes later use.
Bioprosthethic Mesh closures: Narrative
Advances in tissue recovery and engineering have driven the marketing of an almost bewildering range of bioprosethic mesh prostheses that provide new options for abdominal wall reconstruction, related to their potential resistance or tolerance of contamination, as well as their potential for native tissue ingrowth. The utility of cross-linking within the product processing is also debated. It has been suggested that these meshes can be employed in early closure of open abdomens as they may allow for an increased intra-peritoneal domain without fistula formation.
Evidence Summary:
47 The overall evidence regarding the use of these products is poor however. Methodologic concerns and substantial bias remains paramount as no MAs, RCTs, or controlled cohort studies have been published. As a result, biologic mesh data is limited to retrospective studies with case series methodology. Furthermore, none of these publications describe surgical indications in a manner that can be extrapolated to other centres. Finally, adequate lengths of follow-up to truly evaluate performance of the product are also unavailable in the literature.
Reccomendation:
The WSACS SUGGESTS NOT to routinely use a management involving the early closure of open abdomens with bioprosthethic meshes compared to alternative strategies
(Management Suggestion 9; GRADE 1D).
Rationale:
It was recognized that there is potential utility in this approach for possibly decreasing overall costs if ICU stays are reduced and readmissions for wound associated complications and recurrences are minimized. However, there is no data as yet, and the financial implications of routine use are great.
Pediatric Management
The Pediatric Sub-Committee of the WSACS also reviewed the main Management Guidelines in regard to their applicability and suitability for children. They accepted six guidelines as is, rejected none, but could not make recommendations regarding the suitabilty for children in six.
Their specific opinions are presented in Table 6.
48 Discussion
In this guideline, the WSACS presented updated consensus definitions and recommendations for management of clinical problems related to IAH/ACS. For any clinical syndrome or disease process, uniform definitions are essential to facilitate effective clinical communication, standardize research, and allow evaluation of literature. This sentiment may be no more so applicable than in reference to the phenomenon of IAP to the point that it impairs organ function.
Despite the fact that IAH could impair the function of many organs, even those distant to the abdomen, has been appreciated by an enlightened few for centuries, if not longer; many contemporary practicing clinicians worldwide remain unaware and/or uninterested in the contemporary management of IAH/ACS.
The stated mission of the WSACS is to promote research, foster education, and improve the survival of patients with intra-abdominal hypertension (IAH) and/or abdominal compartment syndrome (ACS). To accomplish these goals it is essential that clear and consistent definitions be promulgated and that clear communication be established among all world-wide stakeholders with an interest in understanding these conditions, guiding principles of the inaugural publications governing definitions, management, and guidelines for research. It was with these principles in mind that the WSACS continued to use the GRADE guidelines for Consensus
Development as the framework for reviewing and updating the definitions and management guidelines. The GRADE system is increasingly becoming a standard expected in guidelines promulgation that is being adopted by numerous respected international organization .
49 The GRADE system provides an objective system to allow Guidelines developers to weight both their subjective strength of a recommendation but also their level of confidence in a the scientific evidence supporting the same recommendation. The system is practical, in that it required clinical judgements to be made, and these judgements are made in the context of weighing the potential harms of any therapy in question, the burdens of that therapy both to the patient and society, and the involved costs. The systems also emphasizes that the four categories of quality, that summarize the evidence (high, moderate, low, or very low), are based on an overall assessment of the QofE of the entire available body of evidence, rather than of any particular study itself. The developers themselves have however, cautioned against an overly mechanistic approach towards evidence raking and down- or upgrading it, recognizing that quality of evidence for any body of work occurs in a continuum of confidence. In the context of making recommendations therefore, the QofE ratings reflect the degree of confidence the panel of expert clinicians had that the estimates of an effect or outcome were adequate to justify a recommended intervention or course of therapy.
The WSACS acknowledges that even the strong recommendations promulgated are based on weak scientific studies, a quandary which may be explained two-fold. It is commonly understood the studying the sickest patients is methodologically difficult and that outcomes are hard to attribute due to multifactorial causality. Further, physicians and surgeons bound to care for the sickest patients often do not have the luxury of time and have to respond immediately to life-threatening developments and complications. The panel brought both academic but much
50 clinical experience to the discussion and this collective clinical experience is likely reflected in the Recommendations and Suggestions, wherein the evidence is reflected in the QofE. With this background, these Guidelines should be used as guides for any institution or clinician to initiate their care of the critically ill, at all times evaluating the patients’ outcomes ideally in a formal research study or at least in an organized fashion. These Guidelines therefore should not be used as performance measures or quality assurance criteria to censure any physician or institution.
In utilizing these definitions and guidelines, any clinician should also be aware that there are continuous developments in medical knowledge and that much scientific study continues world- wide in all disciplines in general, as well focusing on IAH/ACS specifically. The panelists made great efforts to review the literature broadly, and to be aware of ongoing research that could influence recommendations, although the reviewers focused on completed peer-reviewed studies that were available in the public domain. Nonetheless it is probable that new knowledge may require revision or modification of this work. Given the lack of high quality evidence to base decision making this is a desirable thing, and thus users are reminded to use these guidelines in the context of knowing their patients well, acting at the bedside, and considering new quality data as it becomes available. Likewise, the WSACS hopes that growth in the body of data from well performed trials justifies further Guidelines revisions on a regular basis.
Future Investigation
51 Despite the ambitious scope of these guidelines and the size of the subsequent reportAnother area was to review which conditions and signs associate with the highest risk of IAH in critically ill patients to allow the correct identification of those who need to be monitored for the development of severe IAH prior to clinical decomposition. Sub-Committees have already begun work on these questions.
Extremes of Age and Habitus
Other areas of uncertainty, not directly addressed by this document relate to what normal values are relevant to use in the very young, the obese, the pregnant, and the elderly. The majority of study has been in adult populations. The WSACS believes that the recruitment of a Pediatric cadre of experts is critical and envisions the future conduct of a dedicated Pediatric Consensus review in order to guide specific efforts in understanding IAH/ACS in children. Likewise, with the obese and pregnant, normal values are not well understood, and in these populations
IAH/ACS may be currently misdiagnosed or alternatively missed when critically ill.
Finally, as the overt ACS becomes less common, and dramatic, the greater question in understanding the relevance of raised IAP In critical illness will shift to the role that more modest reductions in organ perfusion play in a multi-factorial manner. Even if IAPs are still under 20 mmHg dramatic reductions in tissue perfusion have still been shown to occur . What role this phenomenon plays in gut ischemia, bacterial translocation, anastomotic and wound breakdown, neurological obtundation among many other “subtle” complications remains largely unknown in humans but is worrisome based on animal models. As the future research focus
52 changes to study more subtle processes with less dramatic outcomes greater numbers of patients will be required increasing the need for more multi-institutional cooperation. While this fact will further challenge researchers the potential benefits to society will likely be much greater as the incidence of IAH dwarfs the incidence of ACS, being nearly ubiquitous in critical illness and injury.
Conclusions
Many milestones have occurred along the path towards understanding the influence of IAH upon the physiology of the critically ill and injured. The ravages of full-blown ACS appear to being mitigated by both an increasing awareness of the condition and practice changes that lessen many of the inciting factors. However, this apparent progress may be illusionary as the scientific evidence supporting nearly all interventions is generally weak. The panel issued a number of recommendations in the setting of low quality of evidence. As much as we believe in the recommended course of action, low quality of underlying evidence indicates need for further research in this area and our recommendations should not be used as performance measures or quality assurance criteria to censure any physician or institution. Nevertheless, sick patients require treatment even in the absence of well proven approaches. As always, the authors anticipate that these definitions and recommendations remain dynamic and look forward to ongoing revision and refinement.
53 Acknowledgements
Ms Michelle Mercado of the Trauma Association of Canada for webhosting and editing.
54 List of Tables and Figures for Annals
Tables.
Table 1 Most Pertinent Management Questions Concerning Intra-Abdominal Hypertension and the Abdominal Compartment Syndrome Table 2 Final 2013 Accepted Consensus Definitions Table 3 Classification Scheme for the Complexity of the Open Abdomen Table 4 Final 2013 Adapted Pediatric Consensus Definitions Table 5. Overview of Structured Clinical Questions.
Table 6. Final 2013 WSACS Consensus Management Statements
Table 7. Opinions of the Pediatric Care Sub-Committee Regarding the Suitibility of the WSACS Management Recommendations for the care of children
Table 8. GRADE Pro Table for Abdominal Perfusion Pressure
Table 9. GRADE Pro Table for Percutaneous Drainage
Table 10. GRADE Pro Table for generic Negative Pressure Wound Therapy
Table 11. GRADE Pro Table for commercial Nehative Pressure Wound Therapy
Figures.
Figure 1. WSACS intra-abdominal hypertension management algorithm introduced in 2007
Figure 2. Previously Suggested Risk Factors for IAH/ACS Promulgated by the WSACS in 2006
55 Table 1. Most Pertinent Management Questions Concerning Intra-Abdominal Hypertension and the Abdominal Compartment Syndrome
1. (Should we measure it?) Does measuring IAP in critically ill or injured patients improve outcomes compared to strategies that do not consider or measure IAP?
2. (How should we treat/interpret IAP?) Do management strategies that use the abdominal perfusion pressure (APP) to guide management improve patient outcomes compared to strategies that do not consider the APP in critically ill adults with IAH (IAP > 12 mmHg) in critical care units?
3. (Should we treat it?) Do overall management strategies attempting to keep standard-state IAP less than 20 mmHg result in improved patients outcomes compared to management strategies (or the lack thereof) that either accept higher IAPs (or ignore IAP altogether) in critically ill adults in critical care units?
4. (How should we treat it non-operatively?) Do management strategies that use percutaneous drainage of intra-peritoneal fluid to reduce the IAP in cases of intra-abdominal hypertension improve patient outcomes compared to strategies that do not use percutaneous drainage in critically ill adults in critical care units?
5. (How should we treat it operatively?) Do management strategies that use decompressive laparotomy to reduce IAP in cases of overt ACS improve patient outcomes compared to strategies that do not use decompressive laparotomy in critically ill adults with ACS in critical care units?
i) With the ACS?
ii) With grade III-IV ACS but no formal definition of the ACS?
6. (How should we avoid it? or How should we deal with the OA?) Does the use of a management strategy involving efforts at closing the fascia of an open abdomen (OA) improve patient outcomes compared to strategies that do not use strategies to close the fascia and which thus accept skin graft closures and delayed reconstruction in those critically ill adults with OAs in critical care units? )
7. (How should we avoid it? or How should we deal with the OA?) Does the use of a management strategy involving abdominal/peritoneal vacuum/suction type dressings improve patient outcomes compared to strategies that do not use peritoneal vacuum drainage in critically ill adults with OAs in critical care units?
56 8. (How should we avoid it? or How should we deal with the OA?) Does the use of a management strategy involving efforts at closing the fascia of an open abdomen (OA) improve patient outcomes compared to strategies that do not use strategies to close the fascia and which thus accept skin graft closures and delayed reconstruction in those critically ill adults with OAs in critical care units
9. (How should we avoid it? or How should we deal with the OA?) Does the use of a management strategy involving the early closure with bioprosthethic meshes improve patient outcomes compared to strategies that do not use bioprosthethic meshes and which thus accept skin graft closures and delayed reconstruction critically ill adults with OAs in critical care units?
10. (How should we avoid it? or How should we deal with the OA?) Does the use of a management strategy involving component parts separation improve patient outcomes compared to strategies that do not use component parts separation critically ill adults with OAs in critical care units?
11. (How should we avoid it?) Does a management strategy attempting to obtain fluid balance in equilibrium or even negative (conservative fluid strategy) after day 3 result in a lower IAP and improved patients outcomes compared to management strategies that either accept a liberal fluid management and will the latter result in higher IAPs in critically ill adults in critical care units?
12. (How should we avoid it?) Does a massive transfusion strategy involving an enhanced ratio of plasma and/or minimizing crystalloid fluids result in a reduced incidence of IAH/ACS and related complications compared to strategies that do not
57 Table 2.
Final 2013 Consensus Definitions of the World Society of the Abdominal Compartment Syndrome
Retained Definitions from the Original Consensus Statements
Definition 1 IAP is the steady-state pressure concealed within the abdominal cavity.
Definition 2 APP=MAP−IAP.
Definition 3 IAH is graded as follows:
grade I, IAP 12–15 mmHg; grade II, IAP 16–20 mmHg; grade III, IAP 21–25 mmHg, grade IV, IAP>25mmHg.
Definitions 4 ACS is defined as a sustained IAP>20mmHg (with or without an APP < 60mmHg) that is associated with new organ dysfunction/failure.
Definition 5 Primary ACS is a condition associated with injury or disease in the abdominopelvic region that frequently requires early surgical or interventional radiological intervention.
Definition 6 Secondary ACS refers to conditions that do not originate from the abdominopelvic region.
Definition 7 The reference standard for intermittent IAP measurement is via the bladder with a maximal instillation volume of 25ml sterile saline.
Definition 8 Definition 4 IAP should be expressed in mmHg and measured at end- expiration in the complete supine position after ensuring that abdominal muscle contractions are absent and with the transducer zeroed at the level of the midaxillary line.
Definition 9 Normal IAP is approximatel 5–7 mmHg in critically ill adults
Definition 10 IAH is defined by a sustained or repeated pathological elevation in IAP≥12mmHg.
Definition 11 Recurrent ACS refers to the condition in which ACS redevelops following ` previous surgical or medical treatment of primary or secondary ACS.
58 New Definitions Accepted by the 2011 Consensus Panel
Definition 12 a Poly-compartment syndrome is a condition where 2 or more compartments have elevated Compartmental pressures.
Definition 13 Abdominal compliance quantifies the ease of abdominal expansion, and is determined by the elasticity of the abdominal wall and diaphragm and is expressed as a change in intra-abdominal volume per change in intra- abdominal pressure.
Definition 14 an open abdomen as any abdomen requiring a temporary abdominal closure due the skin and fascia not being closed after laparotomy. The type of temporary closure should be explicitly stated.
Definition 15 Pathophysiological Classification of the Open Abdomen 1A = clean-no fixation; 1B = contaminated no fixation; 2A= clean developing fixation; 2B = contaminated developing adhesions; 3 = “Frozen Abdomen” with complete fixation 4 = “Frozen abdomen” with enterocutaneous fistula
(This is a re-arrangement of the original Bjorck classification in regards to the importance of an enterocutaneous fistula in the open abdomen)
Definition 16 Lateralization of the abdominal wall refers to the phonomenon whereby the musculature of the abdominal wall most well see by the rectus abdominus muscles move lateraly away from the midine with time and the lateral gutters become obliterated
Specific Pediatric Definitions
To be refined as a standalone future document by the Pediatric Care Committee of the WSACS
59 Table 3 Classification Scheme for the Complexity of the Open Abdomen
Pathophysiological Classification of the Open Abdomen
1 – No Fixation 1A:clean, no fixation 1B: contaminated, no fixation 1C: enteric leak, no fixation
2 – Developing Fixation 2A: clean, developing fixation 2B: contaminated, developing fixation 2C: enteroatmospheric/cutaneous fistula, developing fixation
3 and 4 – Frozen Abdomen 3: frozen abdomen, no fistula 4: frozen abdomen with enteroatmospheric/cutaneous fistula
(This is an update of the original Bjorck classification regarding the importance of an enterocutaneous fistula in the open abdomen)
60 Table 4 Final 2013 Adapted Pediatric Consensus Definitions
Definitions Accepted Without Change from the Adult Guidelines 1. Intra-abdominal pressure (IAP) is the steady-state pressure concealed within the abdominal cavity. (Accepted unchanged) 2. Abdominal perfusion pressure (APP) = Mean arterial pressure (MAP) minus IAP (Accepted unchanged) 3. Primary ACS is a condition associated with injury or disease in the abdominopelvic region that frequently requires early surgical or interventional radiological 4. Secondary ACS refers to conditions that do not originate from the abdominopelvic region.
5. IAP should be expressed in mmHg and measured at end-expiration in the complete supine position after ensuring that abdominal muscle contractions are absent and with the transducer zeroed at the level of the midaxillary line. 6. Recurrent ACS refers to the condition in which ACS redevelops following previous surgical or medical treatment of primary or secondary ACS. 7. A polycompartment syndrome is a condition where 2 or more compartments have elevated compartment pressures. 8. An Open Abdomen is one in which the abdominal viscera are exposed to the outside environment or retained by a non-autologous artificial barrier which should be explicitly described. 9. Pathophysiological Classification of the Open Abdomen
1A:clean, no fixation 1B: contaminated, no fixation 1C: enteric leak, no fixation 2A: clean, developing fixation 2B: contaminated, developing fixation 2C: enteroatmospheric/cutaneous fistula, developing fixation 3: frozen abdomen, no fistula 4: frozen abdomen with enteroatmospheric/cutaneous fistula
61 This allows recognition of the significant increase in morbidity and mortality in the presence of an enteric leak/fistula in the lower grades while maintaining sufficient similarity to the original classification system that comparison with previous studies could be possible.
10. Abdominal wall compliance defines a concept regarding the ease of expansion of the abdominal wall and its contents which is determined by the overall intra-abdominal volume and elasticity of the abdominal wall.
Proposed Pediatric Specific Definitions 1. ACS in children is defined as a sustained elevation in IAP of greater than 10mmHg associated with new or worsening organ dysfunction that can be attributed to elevated IAP 2. The reference standard for intermittent IAP measurement in children is via the bladder using 1 ml/kg with a minimal instilltion volume of 3ml and a maximum instillation volume of 25ml of sterile saline. 3. Normal IAP in critically ill children is approximately 4 - 10mmHg. 4. IAH in children is defined by a sustained or repeated pathological elevation in IAP > 10mmHg
62 Table 5. Overview of Structured Clinical Questions.
Section No., PICO Question Informal Population Interventions Comparator Outcomes Methodology Question ICU patients 1) Whether ICU patients IAP No IAP Mortality, RCTs, at risk for to measure measurement measurement length of observational IAH or ACS IAP hospital or studies ICU stay, acute renal failure ICU patients 2) Whether ICU patients IAH IAH Mortality, RCTs, with IAH to use APP with IAH management management length of observational to guide strategies that strategies that hospital or studies management use APP do not ICU stay, consider APP acute renal failure ICU patients 3) Whether ICU patients Strategy A Mortality, RCTs, to keep fluid attempting to comparatively length of observational balance obtain a neutral more liberal hospital or studies neutral or or even fluid ICU stay, even negative fluid management acute renal negative balance after strategy failure, ACS, ICU day 3 IAP Critically 4) Whether Critically Damage No damage Mortality, RCTs, injured to use injured control control length of observational trauma damage trauma resuscitation resuscitation hospital or studies patients with control patients with (permissive ICU stay, IAP, massive resuscitation massive hypotension, ACS hemorrhage hemorrhage higher ratios of PRBCs to platelets and plasma, and limited crystalloids) ICU patients 5) Whether ICU patients Percutaneous Usual care Mortality, RCTs, with IAH or to use a with IAH or catheter length of observational ACS percutaneous ACS drainage of hospital or studies drainage intra- ICU stay, catheter abdominal development fluid of ACS or requirement for decompressive laparotomy, acute renal failure, effect on IAP ICU patients 6) Whether ICU patients Strategy aimed No IAP Mortality, RCTs, with IAH to keep IAP with IAH at keeping IAP management length of observational less than 20 less than 20 strategy hospital or studies mmHg mmHg ICU stay, ACS,
63 requirement for decompressive laparotomy, acute renal failure, health- related quality of life ICU patients 7) Whether ICU patients Decompressive No Mortality, RCTs, with IAH to treat IAH with IAH laparotomy decompressive length of observational operatively laparotomy hospital or studies ICU stay, acute renal failure Trauma or 8) Whether ICU patients Fascial closure Use of the Mortality, RCTs, surgery to close the with open during the planned primary fascial observational patients fascia or abdominal hospital stay ventral hernia, closure, length studies requiring utilize a wounds skin grafts, of hospital and open planned and/or delayed ICU stay, abdominal ventral fascial closure abdominal management hernia fistulae, intra- 9a) Whether Trauma or ABThera open Any other abdominal to use NPWT surgery abdomen NPT TAC infection, IAH, for patients system, KCI technique ACS temporary requiring VAC, or abdominal open Barker’s closure abdominal vacuum pack management technique 9b) Whether Same ABThera open Barker’s to use abdomen NPT vacuum pack commercial system, KCI technique NPWT for VAC temporary abdominal closure 9c) Choice of Same ABThera open ABThera open commercial abdomen NPT abdomen NPT NPWT for system, KCI system, KCI temporary VAC VAC abdominal closure 10) Whether Trauma or Bioprosthetic No to use surgery meshes bioprosthetic bioprosthetic patients with meshes meshes open abdominal wounds 11) Whether Trauma or Acute No component to use acute surgery component parts component patients with parts separation parts open separation separation abdominal wounds Where ACS indicates abdominal compartment syndrome; APP, abdominal perfusion pressure; IAH, intra-abdominal hypertension; IAP, intra-abdominal pressure; ICU, intensive care unit; KCI, Kinetic Concepts Incorporated; NPT,
64 negative pressure therapy; NPWT, negative pressure wound therapy; RCTs, randomized controlled trials; VAC, vacuum-assisted closure.
65 Table 6 Final 2013 WSACS Consensus Management Statements
Recommendations 1) Measure IAP when any known risk factor is present in a critically ill/injured patient 2) Studies adopt the current and accepted standard IAP measurement technique 3) A protocolized monitoring and management of intra-abdominal pressure should be utilized when caring for the critically ill/injured. 4) Efforts and/or protocols be utilized to avoid sustained IAH in criticaly ill patients. 5) Efforts and/or protocols be utilized to obtain early or at least same-hospital-stay fascial closure 6) Use DCL to reduce IAP in cases of overt ACS 7) Negative pressure therapy should be utilized to faciltate earlier fascial closure.
Suggestions 1) Critically ill/injured should receive optimal pain and anxiety relief 2) Brief trials of neuromuscular blockade may temporize the treatment of IAH 3) The potential contribution of body position in elevating IAP should be considered in patients with moderate to severe IAH or ACS 4) Use a protocol to try to avoid a positive cumulative fluid balance in the critically ill with, or at risk of IAH
5) Use an enhanced ratio of plasma to packed red blood cells should be considered during resuscitation from massive hemmorhage 6) Use percutaneous drainage to remove fluid in those with IAH/ACS when this is technically possible whether the alternative is doing nothing or a decompressive laparotomy. 7) Physiologicaly exhausted post-trauma laparotomy patients should utilize a prophylactic open abdomen strategy. 8) Intra-peritoneal contamination (even if severe) is NOT an indication for the routine or prophylactic use of the OA technique. 9) Biological meshes should NOT be routinely utilized to faciltate early acute fascial closure.
66 No Recommendations 1) No recommendation was made regarding the use of the abdominal perfusion pressure as a resuscitation marker. 2) No recommendation was made regarding the use of diuretics to mobilize fluid in hemodynamicaly stable patients with IAH. 3) No recommendation was made regarding the use of renal replacement therapies to mobilize fluids in hemodynamically stable patients with IAH. 4) No recommendation was made regarding the administration of albumin to mobilize fluids in hemodynamically stable patients with IAH 5) No recommendation could be made to utilize the component separation technique to facilitate earlier acute fascial closure 6) No recommendation was made regarding the use of the OA technique in emergency surgery in patients with physiologic exhaustion
67 Table 7. Opinions of the Pediatric Care Sub-Committee Regarding the Suitibility of the WSACS Management Recommendations for the care of children
Definitions accepted as appropriate
1) Measure IAP when any known risk factor is present in a critically ill/injured patient 2) A protocolized monitoring and management of intra-abdominal pressure should be utilized when caring for the critically ill/injured. 3) Use percutaneous drainage to remove fluid in those with IAH/ACS when this is technically possible whether the alternative is doing nothing or a decompressive laparotomy. 4) Use DCL to reduce IAP in cases of overt ACS 5) Negative pressure therapy should be utilized to faciltate earlier fascial closure. 6) Use a protocol to try to avoid a positive cumulative fluid balance in the critically ill with, or at risk of IAH
Definitions not accepted as appropriate for Pediatric Care that were not supported for Adult Care
1) No recommendation was made regarding the use of the abdominal perfusion pressure as a resuscitation marker. 2) No recommendation was made regarding the use of DCL for patients with severe IAH but without formal ACS 3) Biological meshes should NOT be routinely utilized to faciltate early acute fascial closure. 4) No recommendation could be made to utilize the component separation technique to facilitate earlier acute fascial closure
5) Use an enhanced ratio of plasma to packed red blood cells during resuscitation from massive hemmorhage 6) Efforts and/or protocols be utilized to obtain early or at least same-hospital-stay fascial closure
68 Table 8. GRADE Pro Table for Abdominal Perfusion Pressure
IAH management strategies that use APP compared to IAH management strategies that do not consider APP for critically ill patients with IAH Bibliography: 1. Vidal et al. Incidence and clinical effects of intra-abdominal hypertension in critically ill patients. Crit Care Med 2008. 2. Dalfino et al. Intra-abdominal hypertension and acute renal failure in critically ill patients. Intensive Care Med 2008. Outcomes No of Quality of the Relative Anticipated absolute effects Participants evidence effect (studies) (GRADE) (95% CI) Risk with IAH management Risk difference with IAH Follow up strategies that do not management strategies that consider APP use APP (95% CI) Mortality 0 See comment OR 0.94 Study population 2 (1 study ) (0.88 to See comment - 0.99)1 Moderate - Acute renal 0 See comment OR 3.41 Study population failure (1 study) (2.02 to See comment - 4.93)3 Moderate - *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio; GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 OR adjusted for APACHE II and McCabe score. 2 Only one study is presented as it examined the prognostic implications of APP among a mixed population of medical and surgical patients, and many other studies did not present their data in a way that could easily be represented in a summary of findings table. 3 Factors included in analyses were IAH, APACHE-II score, filtration gradient, surgical admission, sepsis, age, systemic arterial hypotension, diabetes mellitus, chronic renal disease, liver disease.
69 Table 9. GRADE Pro Table for Percutaneous Drainage
Percutaneous catheter drainage of intra-abdominal fluid compared to usual care for ICU patients with IAH or abdominal compartment syndrome Bibliography:
Outcomes No of Quality of the Relative Anticipated absolute effects Participants evidence effect (studies) (GRADE) (95% CI) Follow up Risk with Usual Risk difference with care Percutaneous catheter drainage of intra- abdominal fluid (95% CI) Mortality 110 ⊕⊝⊝⊝ RR 0.52 215 per 1000 103 fewer per 1000 (1 study) VERY LOW1,2 (0.2 to (from 172 fewer to 71 (RCT) due to risk of bias, 1.33) more) indirectness, imprecision 62 ⊕⊕⊝⊝ RR 0.68 613 per 1000 196 fewer per 1000 (1 study) LOW (0.42 to (from 355 fewer to 80 (matched cohort 1.13) more) study) Length of hospital stay 110 ⊕⊕⊝⊝ The mean length of The mean length of (1 study) LOW1 hospital stay in the hospital stay in the (RCT) due to risk of bias control groups was intervention groups was 28.28 days 12.69 lower (11.03 to 14.35 lower)3 62 ⊕⊕⊝⊝ The mean length of The mean length of (1 study) LOW hospital stay in the hospital stay in the (matched cohort control groups was intervention groups was study) 49 days 9 lower (21.7 lower to 3.7 higher) Requirement for 62 ⊕⊝⊝⊝ RR 0.68 806 per 1000 258 fewer per 1000 4 decompressive (1 study) VERY LOW (0.28 to (from 581 fewer to 153 (matched cohort due to indirectness 1.19) more) laparotomy study) Intra-abdominal 12 See comment Not See comment See comment 5 Pressure (1 study ) estimable (before-after case series) *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 In this RCT conducted in China, 45 patients were randomly allocated to PCD [mean duration of drainage, 3.5 (SD, 0.85) days] while 65 were randomized to "control." Control group treatments appeared common across both groups, and included short veno- venous hemofiltration, "gastrointestinal TCM ablution [which was undefined by the study authors]," respiration support, and Dahuang
70 or Qingyitang "infused by gastric canal or anal drip (3 times daily)." In addition the the uncertain nature of the addition treatments, other limitations of this trial included the lack of description of the randomization procedure, the likely lack of adequate allocation concealment, and the finding that the mortality rate numbers did not add up. 2 Although the numbers for the estimated risk of mortality among the two groups did not add up for this RCT [a mortality rate of 10% was reported for the 45 PCD treated patients (suggesting that 4.5 patients died) versus 20.7% of the 65 control group patients (suggesting 13.5 patient deaths)], rounding up to 5 patient deaths in the PCD group versus 14 patient deaths in the control group yields a relative risk that ranges from significant PCD benefit to possible harm. 3 Calculated using a two-sided, two-sample t-test comparing the PCD [45 patients with a mean length of hospital stay=15.59 (SD, 3.89)] and control (65 patients with a mean length of hospital stay=28.28 (SD, 4.61)] groups. 4 In this severity of illness-matched cohort study, 81% of patients with IAH and comorbidities that could be considered indications for open abdominal decompression had their IAP values decreased significantly, and therefore may have avoided decompressive laparotomy. 5 Before-after uncontrolled case series with lack of correction for factors known to influence intra-abdominal pressure.
71 Table 10. GRADE Pro Table for generic Negative Pressure Wound Therapy
NPWT (KCI VAC, ABThera, or Barker's vacuum pack technique) compared to an alternative temporary abdominal closure technique (mesh closure) for critically ill trauma or surgery patients with open abdominal wounds Bibliography: 1. Roberts DJ, Zygun DA, Grendar J, Ball CG, Robertson HL, Ouellet JF, Cheatham ML, Kirkpatrick AW. Negative pressure wound therapy for critically ill adults with open abdominal wounds: a systematic review. J Trauma Acute Care Surg 2012 (in press). 2. Quyn AJ, Johnston C, Hall D, Chambers A, Arapova N, Ogston S, Amin AI. The open abdomen and temporary abdominal closure systems - historical evolution and systematic review. Colorect Dis 2012. Accepted Article. doi: 10.1111/j.1463- 1318.2012.03045.x
Outcomes No of Participants Quality of the Relative Anticipated absolute effects (studies) evidence effect Follow up (GRADE) (95% CI) Risk with An Risk difference with alternative NPWT (KCI VAC, temporary abdominal ABThera, or Barker's closure technique vacuum pack (mesh closure) technique) (95% CI) Mortality 51 ⊕⊕⊝⊝ RR 1.0 250 per 1000 0 fewer per 1000 (1 study) LOW1 (0.39 to (from 153 fewer to 428 (RCT) due to imprecision 2.71) more) 3000 ⊕⊝⊝⊝ RR 0.75 298 per 10002 74 fewer per 1000 (68 studies) VERY LOW2,4 (0.66 to (from 48 fewer to 101 (systematic review of due to risk of bias, 0.84)3 fewer) predominantly indirectness observational studies on NPWT) Primary fascial 51 ⊕⊕⊕⊝ RR 1.94 250 per 1000 235 more per 1000 5 closure (1 study) MODERATE (0.83 to (from 43 fewer to 872 (RCT) due to imprecision 4.49) more) 3000 ⊕⊝⊝⊝ RR 1.62 357 per 10002 221 more per 1000 (68 studies) VERY LOW2,4 (1.49 to (from 175 more to 271 (systematic review of due to risk of bias, 1.76)3 more) predominantly indirectness observational studies on NPWT) Length of hospital - See comment Not See comment See comment or ICU stay - not estimable reported Abdominal 51 ⊕⊕⊝⊝ RR 3.87 50 per 1000 144 more per 1000 6 fistula(e) (1 study) LOW (0.5 to (from 25 fewer to 1000 (RCT) due to risk of bias, 29.8) more) imprecision 3000 ⊕⊝⊝⊝ RR 0.93 75 per 10002 5 fewer per 1000 (68 studies) VERY LOW2,4 (0.72 to (from 21 fewer to 16 (systematic review of due to risk of bias, 1.21)3 more) predominantly indirectness observational studies on NPWT) Intra-abdominal 51 ⊕⊕⊝⊝ RR 0.86 450 per 1000 63 fewer per 1000 1,6 abscess(es) (1 study) LOW (0.45 to (from 248 fewer to 297 (RCT) due to risk of bias, 1.66) more) imprecision 3000 ⊕⊝⊝⊝ RR 0.86 87 per 10002,7 12 fewer per 1000 (68 studies) VERY LOW2,4 (0.45 to (from 48 fewer to 57 (systematic review of due to risk of bias, 1.66)3 more) predominantly indirectness, observational studies on imprecision NPWT)
72 Costs 51 ⊕⊕⊕⊝ The mean costs in the The mean costs in the (1 study) MODERATE8 control groups was intervention groups was (RCT) due to risk of bias 474.24 $ per patient 857.39 higher requiring open (0 to 0 higher) abdominal management *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 Downgraded in quality as the 95% CI for the estimated RR included values suggesting the possibility of significant benefit or harm. 2 In this systematic review, a weighted pooled outcomes analysis of the risk of various outcomes was performed using case series, cohort studies, and one randomized controlled trial. However, frequently the included studies did not perform a "head-to-head" comparison of alternate temporary abdominal closure techniques. 3 These RR estimates are based on unweighted and indirect comparison data from a systematic review of case series of temporary abdominal closure with the NPWT versus mesh. 4 Limtations of the studies included in this systematic review include their often uncontrolled study design, lack of description of temporary abdominal closure indications, the frequently inadequate delineation of important co-variates known to influence mortality, fascial closure, or length of hospitalization, and the use of absolute or relative effect measures that were often unadjusted for important clinical or laboratory characteristics. 5 Downgraded in quality as the 95% CI suggests a possible benefit of negative pressure wound therapy, but varies widely and includes the null value. 6 Downgraded as all of the included patients were fitted with gastric or jejunal feeding tubes, and all of the abdominal fistulae developed in those treated wtih Barker's vacuum pack NPWT technique. 7 In order to match the control group for the presented randomized trial, we reported the mortality risk for the mesh treatment group from the this systematic review and weighted pooled outcomes analysis of predominantly observational studies. 8 Downgraded in quality as only supplies-related costs were considered in the analysis.
73 Table 11. GRADE Pro Table for commercial Negative Pressure Wound Therapy
Commercial NPWT (KCI VAC, ABThera) compared to Barker's vacuum pack technique for critically ill adults with open abdominal wounds Bibliography:
Outcomes No of Participants Quality of the evidence Relative Anticipated absolute effects (studies) (GRADE) effect Follow up (95% CI) Risk with Risk difference Barker's with Commercial vacuum pack NPWT (KCI VAC, technique ABThera) (95% CI) Mortality 168 ⊕⊕⊕⊝ RR 0.48 263 per 1000 137 fewer per 1000 (1 study) MODERATE1,2 (0.25 to (from 21 fewer to 197 (prospective cohort due to risk of bias, large 0.92) fewer) study of the ABThera effect NPT system) 1437 ⊕⊝⊝⊝ Not 287 per 1000 287 fewer per 1000 (23 studies) VERY LOW3,4,5,6 estimable (from 287 fewer to (systematic review of due to risk of bias, 287 fewer) case series) inconsistency, indirectness, large effect Primary fascial closure 31 ⊕⊝⊝⊝ RR 2.60 231 per 1000 369 more per 1000 (1 study) VERY LOW7,8 (0.95 to (from 12 fewer to (RCT of the KCI VAC) due to indirectness, 7.1) 1000 more) imprecision 168 ⊕⊝⊝⊝ RR 1.5 263 per 1000 132 more per 1000 (1 study) VERY LOW1,2,8 (1.1 to 2) (from 26 more to 263 (prospective cohort due to risk of bias, more) study of the ABThera imprecision, large effect NPT system) 1437 ⊕⊝⊝⊝ Not 515 per 1000 515 fewer per 1000 (23 studies) VERY LOW3,5,9,10 estimable (from 515 fewer to due to risk of bias, 515 fewer) inconsistency, indirectness, large effect Length of hospital or ICU 0 See comment Not Study population stay (0) estimable See comment - not reported by the one Moderate RCT or cohort study, or the - systematic review of case series. Abdominal fistulae 0 See comment Not Study population (23 studies) estimable See comment - Moderate -
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect.
74 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 As this prospective multicenter cohort study is not yet published, its abstract data were taken from a systematic review of comparative studies. Therefore, a complete quality assessment is not yet available and these data could be linked with a risk of bias. 2 In this prospective cohort study, the beneficial effect of the ABThera over Barker's vacuum pack technique on mortality was very large and on primary fascial closure was large. 3 Limitations of the case series included in this systematic review include their often uncontrolled study design, lack of description of temporary abdominal closure indications, the frequently inadequate delineation of important co-variates known to influence mortality, fascial closure, or length of hospitalization, and the use of absolute or relative effect measures that were often unadjusted for important clinical or laboratory characteristics. 4 The risk of mortality following temporary abdominal closure with the "VAC" (KCI VAC largely) varied from 7% to 33% in the case series included in this systematic review. 5 In this systematic review, a weighted pooled outcomes analysis of the risk of various outcomes was performed using case series. However, the included studies did not perform a "head-to-head" comparison of alternate temporary abdominal closure techniques. 6 The reduction in the risk of mortality across individual case series was often considerably larger when indirectly compared across case series reporting on different temporary abdominal closure techniques. 7 Although this RCT began by allocating patients to either Barker's vacuum pack technique or polyglactin mesh, the investigators later altered their study protocol and form of NPWT to the KCI VAC. Therefore, an indirect comparison of fascial closure between the KCI VAC and Barker's vacuum pack technique was possible. 8 The 95% RR for primary fascial closure was close to, or included, the null value. 9 The percentage of patients who achieved fascial closure in the case series included in this systematic review varied from 33% to 100% with the VAC (the KCI VAC frequently) and 18% to 91% with Barker's vacuum pack technique. 10 In this systematic review of case series, the VAC was second only to the artificial burr, or Whittmann's patch, in the improvement in the percentage of fascial closure.
75 76 Figure 1 WSACS intra-abdominal hypertension management algorithm introduced in 2007
77 Figure 2 Previously Suggested Risk Factors for IAH/ACS Promulgated by the WSACS in 2006
From Malbrain et al.,
78 Pediatric Guidelines Sub-Committee
Chair: Janeth Chiaka Ejike, Loma Linda, California Members: Francisco Diaz, MD, Torsten Kaussen, MD, Mudit Mathur, MD, Rebecka Meyers, MD, Donald Moores, MD Michael Sasse, MD
79 References
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