Kidney360 Publish Ahead of Print, published on June 5, 2020 as doi:10.34067/KID.0001132020
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REDUcing the burden of dialysis Catheter ComplicaTIOns: a National approach (REDUCCTION) – design and baseline results
Sradha Kotwal1,2, Sarah Coggan1, Stephen McDonald3, Girish Talaulikar4, Alan Cass5, Stephen Jan1, Kevan R. Polkinghorne6,7, Nicholas A. Gray8,9, Martin Gallagher1,10 on behalf of the REDUCCTION project investigators (detailed in Appendix)
1. The George Institute for Global Health, UNSW, Sydney, Australia 2. Department of Nephrology, Prince of Wales Hospital, Sydney, Australia 3. ANZDATA Registry, Adelaide, South Australia 4. Renal Services, ACT Health, Canberra, ACT 4. Concord Clinical School, University of Sydney, Sydney, Australia 5. Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia 6 Department of Epidemiology and Preventive Medicine, Monash University, Prahran, Victoria 7. Departments of Nephrology & Medicine, Monash Medical Centre, Monash University, Clayton, Victoria, Australia 8 Sunshine Coast University Hospital, Birtinya, Australia 9. University of the Sunshine Coast, Sippy Downs, Australia 10. Concord Clinical School, University of Sydney, NSW
Corresponding author Dr. Sradha Kotwal The George Institute for Global Health Renal and Metabolic Division Level 5, 1 King Street Newtown Sydney, N/A 2041 Australia [email protected]
Copyright 2020 by American Society of Nephrology. 2
Abstract
Background Patients with hemodialysis central venous catheters (HD CVC) are susceptible to health care associated infections, particularly hemodialysis catheter related blood stream infection (HD-CRBSI), which is associated with high mortality and health care costs. There have been few systematic attempts to reduce this burden and clinical practice remains highly variable. This manuscript will summarize the challenges in preventing HD-CRBSI and describe the methodology of the REDUcing the burden of dialysis Catheter ComplicaTIOns – a National approach (REDUCCTION) trial.
Methods The REDUCCTION trial is a stepped wedge cluster randomized trial of a suite of clinical interventions aimed at reducing HD-CRBSI across Australia. It clusters the intervention at the renal service level with implementation randomly timed across three tranches. The primary outcome is the effect of this intervention upon the rate of HD-CRBSI.
Patients who received a HD CVC at a participating renal service are eligible for inclusion. A customized data collection tool allows near to real-time reporting of the number of active catheters, total exposure to catheters over time and rates of HD-CRBSI in each service.
The interventions are centered around the insertion, maintenance and removal of HD CVC, informed by the most current evidence at the time of design (mid-2018).
Results A total of 37 renal services are participating in the trial. Data collection is ongoing with results expected in the last quarter of 2020. The baseline phase of the study has collected provisional data on 5385 catheters in 3615 participants, representing 603,506 days of HD CVC exposure.
Conclusion The REDUCCTION trial systematically measures the use of HD CVCs at a national level in Australia, accurately determines the rate of HD-CRBSI and tests the effect of a multifaceted, evidence-based intervention upon the rate of HD-CRBSI. These results will have global relevance in nephrology and other specialties commonly using CVCs.
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Introduction
Patients receiving hemodialysis are highly susceptible to healthcare-associated infections. Most prominent among these infections is hemodialysis catheter-related bacteremia (HD-CRBSI), which is associated with high mortality and high health care costs.(1) Hemodialysis central venous catheters (HD CVC) are ubiquitous in modern nephrology; used in up to 80% of incident maintenance hemodialysis patients, 20% of prevalent hemodialysis patients and universally in patients requiring hemodialysis for acute kidney injury.(2-5)
HD-CRBSI is associated with risks beyond the primary event, such as endocarditis, major organ abscesses, recurrent sepsis and mortality. A 2013 meta-analysis concluded that the healthcare cost per episode of all CVC-related bacteremia, including HD-CRBSI, in the USA was $45,814 (95% CI $30,919- $65,245), constituting 18.9% of the total national cost of healthcare-associated infections or $1.85b per annum.(1) These costs exclude the impact on the patient’s quality of life from additional catheters, hospital admissions and medical procedures.
There have been few systematic attempts to reduce this burden in dialysis services, and clinical practice remains highly variable.(6) Many interventions have been studied with the aim of reducing HD-CRBSI, and the nature of this literature has likely contributed to practice variation.(6-9) The recent Making Dialysis Safer for Patients Coalition initiative, led by the Centers for Disease Control and Prevention (CDC), is testament to the need for standardized approaches to infection prevention in dialysis services as was the success of the Keystone Michigan Project.(10, 11) Herein, we review the research that formed the basis of the design and protocol of the REDUcing the burden of dialysis Catheter ComplicaTIOns – a National approach (REDUCCTION) trial, a stepped-wedge cluster randomized clinical trial of a suite of clinical interventions aimed at reducing the rate of HD-CRBSI across Australian renal services.
Challenges in reducing HD-CRBSI
1. Reporting and comparison of rates of HD-CRBSI A crucial requirement for the implementation and evaluation of strategies to reduce HD- CRBSI is the ability to accurately measure and report the disease burden. While measurement has been done well in RCTs and prospective studies, sustainable, system-wide measurement in clinical practice can be difficult. Historically, HD-CRBSI rates have used different definitions and denominators, with the numerator usually being HD-CRBSI events and denominators using variable measures of catheter exposure, making comparisons difficult.(12, 13) Furthermore, the lack of clinical adjudication of BSI also adds uncertainty around the true rate of HD-CVC BSI. Our survey of ANZ renal services found 84% of services were collecting data on HD-CRBSI rates but only 51% could report a rate.(6) The reported HD-CRBSI rates in the literature vary widely, with published rates of 1.1 - 5.5 episodes per 1000 days of catheter exposure at the time of design of the REDUCCTION trial.(14-17) Studies published from USA and Canada subsequently have published much lower rates of between 0.19-0.84 per 1000 catheter days, making it difficult for clinicians to ascertain appropriate targets.(13, 18) 4
2. Complex care There are many components to catheter care, with breakdown in any element likely to influence the risk of HD-CRBSI. Published research has focused upon the use of prophylactic antimicrobial agents, either applied topically to the catheter exit site, or as solutions to ‘lock’ the catheter lumen after insertion and between dialysis treatments, as well as non-microbial agents such as citrate taurolidine, and chlorhexidine.(8, 19, 20) Other interventions include catheter dressing types (21), catheter dressing frequency (22), catheters with subcutaneous tunnels (23) and, more recently, antimicrobial catheter lumen caps that form a physical and antimicrobial barrier at the closure of the dialysis catheter.(24) A recent review highlighted the complexity of this literature, presenting challenges for clinicians in untangling the evidence to decide upon optimal catheter care.(25) In addition, various hospital departments may play a role in managing any single HD CVC complicating care and making standardization difficult.(6)
3. Evidentiary limitations The difficulties posed by the literature examining HD-CRBSI are perhaps best illustrated by the differing and often outdated recommendations from guideline groups. The Australia/New Zealand (ANZ) guideline, published in 2012, made a single recommendation based upon high grade (level 1) evidence, and the Canadian guidelines from 2006 made two recommendations with high level evidence.(26, 27) The US guidelines published in April 2020 make multiple recommendations around the use, insertion, management and removal of HD-CVC’s most of which remain based on expert opinion or at best moderate level of evidence.(28) .(29) The limited recommendations, whilst reflecting the available literature at the time of guideline production, is a notable contrast to the myriad elements of catheter insertion, management and care. The guidelines also highlight the gaps in this literature, most notably the paucity of head-to-head studies comparing differing treatments and approaches, such that their relative benefits remain unclear. (23)
In contrast, the CDC guidelines for the prevention of intravascular catheter-related infections updated in 2017 cover 20 sub-topic areas, illustrating the complexity of what most clinicians would consider a relatively routine part of clinical nephrology care.(30) The final recommendation, that of using collaborative performance improvement initiatives and multi-faceted strategies to improve practice, has been central to the development of the REDUCCTION trial.
Many other elements such as insertion site, showering/bathing, use of sterile techniques at insertion and when accessing the catheter, frequency of dressing changes and patient factors (such as socioeconomic status, comorbidities, residence characteristics and patients’ understanding of catheter care) could also influence HD-CRBSI, but are not readily studied. Furthermore, much of the current evidence arises from small studies, many of low quality, testing differing interventions with variable outcome reporting. These characteristics make the distillation of findings into a coherent and implementable practice change at a service level difficult and allow variability in clinical practice to flourish.(25, 31-33) 5
4. Practice variation A survey of ANZ renal services demonstrated wide variation in the processes around catheter care, such as prophylactic antibiotic use, exit site dressings and catheter insertion personnel.(6, 34) This showed that prophylactic antibiotics were used at 21% of renal services and eight different combinations of exit site dressing were in use, with an antibiotic patch being most common (35%).(6)
Reducing such variation has, had some success in reducing CVC-related bacteremia. The Keystone ICU project used a suite of interventions to address healthcare-associated infections, most notably CVC-associated bacteremia, and showed significant reductions in this outcome.(11)
The REDUCCTION trial aims to systematically measure the use of HD CVCs for dialysis access at a national level in Australia, to accurately determine the rate of HD-CRBSI and test the effect of a multifaceted, evidence-based intervention upon the rate of HD-CRBSI.
Methods
Design REDUCCTION uses a stepped-wedge cluster design (Figure 1) (35), clustering the intervention at the renal service level, ensuring that all participating services receive the intervention and serve as their own control. The application of such an intervention at the individual patient level was impractical due to the requirement of having two (or more) systems of HD CVC management within each service and the risk of “contamination” of the intervention practices into the control group. This approach implements the entire suite of interventions at a service level, minimizing contamination, uses the benefits of randomization in the timing of the application of the intervention, and accommodates for changes in practice that occur with time. The trial was registered on the Australia New Zealand clinical trials registry on the 23 June 2016 (ACTRN12616000830493).
Setting The trial is being conducted at 37 renal services across Australia which, collectively, manage 75% of the Australian prevalent dialysis population (Table 1). Many services oversee multiple dialysis facilities, such that a service is defined as a site, or sites (usually hospital-based in Australia), under the same clinical governance as it pertains to clinical decision making around HD CVC management. Australia has a universal health insurance system, covering the costs of inpatient public hospital care and varying proportions of outpatient health services. Dialysis is largely provided in public hospitals and is covered by the national insurance scheme, and private facilities manage a small proportion of dialysis patients.
Participant inclusion criteria All Australian renal services were approached to participate in the trial in 2016, with 37 proceeding to enrolment. Adult patients who have a HD CVC inserted after the start of the trial at a participating renal service are eligible for inclusion in the data collection. Prevalent dialysis catheters inserted 6
prior to the start of the trial are excluded. Data are collected from the time of HD CVC insertion, or the time the HD CVC comes under the care of the renal service, until the HD CVC is removed, no longer under the care of the renal service, or end of the trial.
Informed Consent Ethics approval was obtained according to institutional processes across 8 states and territories (Supplemental Table 1). The trial uses two approaches to consent; an ‘opt-out’ approach or a ‘waiver of consent’ approach, as decided by local research governance.(Table 1) Renal services using the ‘opt-out’ approach allow patients to opt-out of the data collection following provision of a trial information sheet, but the renal service continues to treat such patients as per the service’s participation in the trial. Services with approval to use the ‘waiver of consent’ approach are not required to perform any study-related consent activities. Any participant is able to decline participation in the data collection at any point in the trial.
Data collection methods A web-based data collection tool was custom designed for the study and data entered by each participating service. Renal services can see, in real-time, all dialysis catheters currently in use, and the total exposure of patients to dialysis catheters over various time periods. Services are able to see their own rates of HD-CRBSI during the baseline phase and, during the trial intervention phase, can also see the HD-CRBSI rate across the entire trial.
The data collection includes baseline patient and catheter characteristics and classifies catheters by their reason for insertion: initiation of maintenance hemodialysis, acute kidney injury requiring hemodialysis (HD CVC is managed by the renal service), interim hemodialysis due to failure of an existing dialysis access e.g. failure of peritoneal dialysis, or thrombosis of an existing arterio-venous fistula. Data on interventions upon the dialysis catheter (e.g. rewiring, re-suturing), surgery for creation or revision of permanent dialysis access, the reasons for catheter removal, and the results of any blood or catheter tip cultures are also collected. (Supplemental Table 3) In addition, service- level data on existing practices around catheter care and dialysis activity within each renal service at trial initiation and prior to implementation is collected. Services were discouraged from making changes to the processes of care for HD CVCs during the baseline phase of the trial.
Reporting of HD-CRBSI uses a standardized definition (Table 2) and a central blinded adjudication process. All possible HD-CRBSI events are reviewed by two adjudicators (clinicians who are independent from the research team). Disagreement between the two adjudicators requires review from the third adjudicator. If agreement is not reached by the third adjudication, the Trial Management Committee) reviews the de-identified event.
Data linkage to state-specific hospitalization and death datasets will complete at the end of the intervention phase, after all trial data collection has ceased, allowing analyses of long-term patient outcomes and economic impacts of catheter complications. 7
Interventions and Implementation The suite of evidence-based interventions, designed by a sub-committee of the REDUCCTION Steering Committee in consultation with the Australasian renal guidelines group (36) and the Australian consumer body (Kidney Health Australia) , was endorsed by the Trial Management Committee. The interventions were informed by the most current evidence at the time of design, including the Keystone Project in Michigan ICUs (15, 16), expert opinion across ANZ and were finalised in January 2018. The components of the intervention were separated into three timepoints in catheter use – insertion, maintenance and removal and were deemed as guiding rather than prescriptive (Figure 2).
All services implemented the entire suite of interventions at their randomly assigned time point, overseen by local physician and nursing leaders. The delivery of the intervention training was in the form of three short videos (one for each component of the intervention) delivered to the service 6 weeks prior to the implementation of the interventions as well as a pre-intervention teleconference. Upon intervention implementation, the data collection tool was modified to allow each service to compare the primary outcome, HD-CRBSI, at their service with the study-wide rate, and additional data prompts and fields were added to remind service staff of the intervention components and allow monitoring. (Supplemental Table 4)
Blinding Blinding of the trial intervention is not possible, but the timing and nature of the trial interventions was kept confidential and revealed prior to implementation at each service. Services were asked to keep the intervention confidential until all services had implemented the intervention.
Outcomes The primary outcome of the trial is the comparative rate of HD-CRBSI per 1000 catheter days of exposure, between the baseline and intervention trial periods (Table 2). A modified version from the the Infectious Diseases Society of America definition was used to define HD-CRBSI as detailed in Table 2.(37) The secondary outcomes are suspected or possible HD-CRBSI; total suspected and possible bacteremia (Table 2).
Statistical methods A covariate-based constrained randomization determined the division of participating services into three balanced tranches and the commencement of the intervention over the trial period.(35, 38) The allocation sequence was informed by the total number of catheters inserted in the baseline phase of the trial (December 2016 - January 2018). One hundred thousand random allocation sequences were generated, and those that achieved a degree of balance of no more than a 10% different from the average number of dialysis catheters in the trial (between 73.2-89.8 average catheters per arm) were retained. Of the original sequences generated, 6865 met our balance criteria, and the final randomization allocation was chosen randomly from this subset.
Pilot data collected from a Sydney service (unpublished) allowed us to estimate that an average of 100 dialysis catheter insertions (100 observations) occurred per year at a medium sized Australian 8
renal service (defined based on number of dialysis patients as per ANZDATA), with each catheter lasting for a mean of 46 days. The expected rate of baseline HD-CRBSI was 2.5 per 1000 catheter days, derived from a combination of pilot data and the published literature at the time.(17) Further considerations included the inter-cluster correlation co-efficient (ICC) which we estimated at 0.07 when the rate seen in a large US study from 2014 was 0.03, (9) and the number of intervention points (number of steps) planned was three. The powering was based upon the intervention resulting in a 50% reduction in the risk of catheter-related bacteremia which was a conservative estimate based on the Key Michigan project outcomes.(11, 39)
On the basis of these figures, the trial was estimated to have a power of over 0.9 to detect a 50% reduction in the bacteremia rate using a proposed sample of 30 renal services following 100 patients per ‘step’ in the stepped-wedge design. This is likely a conservative figure as the ICC in other studies has been substantially lower, the number of patients per ‘step’ is likely to be more than 100 as the duration of follow-up post-intervention is longer for some services, and the trial has included 37 renal services to ensure that 100 patients per ‘step’ during implementation is met. A formal statistical analysis plan has been derived for the trial and will be published on the REDUCCTION study site. (URL to be confirmed).
Additional analyses There are two planned sub-group analyses of the primary outcome. The first examining for differences in the primary outcome on the basis of renal service size, and the second on the basis of whether renal services were using either an impregnated dressing or an antimicrobial catheter lock, as per the KHA-CARI guidelines (27), at baseline. A prospective process evaluation is being conducted during the baseline and intervention phases of the trial to better understand the factors that influence the implementation of evidence-based practices around dialysis catheter management.(40)
In addition, this uniquely large prospective cohort of patients receiving dialysis catheters will allow future exploration of the effects of a variety of factors, including renal service, patient, clinical and HD CVC characteristics upon important patient outcomes such as HD-CRBSI, hospitalization, and mortality. These analyses will use trial data and linkage to administrative (hospitalization and death) datasets, allowing assessments of the healthcare costs of catheter practice.
Key Limitations A limitation of the trial and its design is that the completeness of data collection is not known, and there is a risk that this could change between baseline and intervention phases. Potentially the risk of the primary outcome across services may also have varied between the two study phases, but the absence of tools to guide clinicians in such patient selection makes this unlikely. Most importantly, the Hawthorne effect may impact the trial outcomes: the phenomenon whereby individuals change their behavior as a result of their knowledge of being observed.(41) To mitigate this, services are discouraged from changing to their clinical practices around catheter care during the trial, beyond those changes arising from the trial intervention. The risk of under-reporting of HD-CRBSI remains but is mitigated by the requirement to centrally report all possible infectious events and the central adjudication of these events. 9
Results
Participant characteristics Data collection commenced on the 20th of December 2016 and is ongoing. A provisional extract from the trial dataset, encompassing the intervention phase at all services, includes data on 5385 HD CVCs in 3615 participants, representing 603,506 days of HD CVC exposure.
The average age of the participants was 63.0 years (IQR 50-73.0 years), 60.1% (n=2174) were male, and 43.7% (n=1578) had diabetes (Table 3). The majority of HD CVCs inserted were tunnelled catheters with a median catheter duration of 90.0 days (IQR 28-207 days). Non-tunnelled HD CVC had a median catheter duration of 6 days (IQR 3-8 days).
The major indications for HD CVC insertion were for acute kidney injury (n=1896, 35.0%), or for initiation of maintenance hemodialysis without permanent access (n=1703, 31.6%) (Table 4). The majority of tunnelled catheters were inserted by interventional radiology services (n=2699; 67%) while the non-tunnelled catheters were inserted predominantly by intensive care units (n=753; 55.8%). The internal jugular vein was the most popular site for HD CVC insertion (total 4619; tunnelled =3780 (81.8%); non-tunnelled= 838 (18.1%)) with femoral being the second most popular site (total 577; tunnelled =83 [14.4%]; non-tunnelled= 494 [85.6%]).
Conclusion
REDUCCTION is a large stepped wedge cluster randomized trial which systematically measures the use of dialysis catheters across 37 Australian renal services in real-time. It will study the effect of a standardized suite of evidence-based interventions around catheter care upon the rate of HD-CRBSI at the service level and, by virtue of its scale and robust design, will provide novel insights into dialysis catheter care and its impacts upon patients.
Disclosures
N. Gray reports personal fees from Baxter Healthcare and non-financial support from Amgen Australia outside the submitted work. M. Gallagher reports grants from Australian National Health and Medical Research Council, non-financial support from Multiple partner hospitals, grants from Victorian Department of Health, and grants from Queensland Depart of Health during the conduct of the study; and The George Institute and its affiliated entities work with numerous health and pharmaceutical companies in the design, implementation and analyses of clinical research and clinical trials. It is possible that some of these companies have products relevant to the clinical space covered in this analysis, but Dr Gallagher is not aware of any possible conflicts arising from this work. All remaining authors have nothing to disclose.
Funding
The REDUcing the burden of dialysis Catheter ComplicaTIOns: a National approach (REDUCCTION) trial is supported by NHMRC Partnership grant (APP1103241), Department of Health Victoria, Queensland Health. The ANZDATA Registry, Kidney Health Australia, Kidney Health Australia – Caring for Australasians with Renal Impairment, Alice Springs Hospital, Royal Darwin Hospital, Royal 10
Adelaide Hospital, Austin Hospital, Alfred Hospital, Eastern health, Monash Medical Centre, Royal Melbourne Hospital, Western Health, Royal Hobart Hospital, Cairns Hospital, Princess Alexandria Hospital, Royal Brisbane Hospital, Sunshine Coast Hospital and health Service, Toowoomba Hospital, ACT/NSWSHLD Renal Network, Concord Repatriation General Hospital, Royal Prince Alfred Hospital, Liverpool Hospital, Nepean Hospital, and the Western Sydney LHD provided in-kind support. S. Kotwal is supported by a MRFF Next Generation TRIP Fellowship (MRF1150335)
Author Contributions S Kotwal: Conceptualization; Formal analysis; Methodology; Project administration; Validation; Writing - original draft; Writing - review and editing S Coggan: Project administration; Writing - review and editing N Gray: Conceptualization; Funding acquisition; Writing - review and editing K Polkinghorne: Conceptualization; Funding acquisition; Methodology; Writing - review and editing S Jan: Funding acquisition; Methodology; Writing - review and editing S McDonald: Conceptualization; Funding acquisition; Methodology; Writing - review and editing G Talaulikar: Conceptualization; Funding acquisition; Methodology; Writing - review and editing A Cass: Funding acquisition; Writing - review and editing M Gallagher: Conceptualization; Funding acquisition; Methodology; Project administration; Resources; Supervision; Writing - review and editing
Supplemental Materials
List of REDUCCTION Partnership Project contributors
Table 1 – Ethics committee and services covered
Table 2 – Allocation schedule
Table 3 - Data collected in the trial/CRF
Table 4 – New questions added in the intervention phase
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14
Tables and Figures
Table 1 – Renal services participating in the trial Number HD patient of Urban/Regional numbers from Service Name State Consent model Satellite * ANZDATA as on Services 31/12/2016 Alice Springs NT 2 Regional Opt-out 358 Armadale Health Service WA 0 Regional Opt-out 53 Austin Health VIC 4 Urban Waiver 243 Cairns Hospital QLD 5 Regional Waiver 266 Concord Hospital NSW 2 Urban Waiver 126 Eastern Health VIC 5 Urban Opt-out 179 Fiona Stanley Hospital WA 7 Urban Opt-out 469 Flinders Medical Centre SA 4 Urban Waiver 218 Geelong Hospital (Barwon Health) VIC 4 Urban Waiver 156 Gold Coast Hospital and Health Service QLD 2 Urban Waiver 151 John Hunter Hospital NSW 5 Urban Waiver 222 Liverpool Hospital NSW 5 Urban Waiver 424 Mackay Hospital QLD 1 Regional Waiver 55 Mater Hospital, Brisbane QLD 2 Urban Waiver 30 Monash Health VIC 5 Urban Waiver 507 Sunshine Coast University Hospital and QLD 3 Urban Waiver 128 Health Service Nepean Hospital NSW 1 Urban Waiver 119 Prince of Wales Hospital NSW 1 Urban Waiver 80 Metro South Hospital and Health Service (including Princess Alexandria Hospital, QLD 3 Urban Waiver 328 Redlands and Logan Hospital) 15
Number HD patient of Urban/Regional numbers from Service Name State Consent model Satellite * ANZDATA as on Services 31/12/2016 Rockhampton QLD 3 Regional Waiver 89 Royal Adelaide Hospital SA 17 Urban Waiver 591 Royal Brisbane Hospital QLD 3 Urban Waiver 229 Royal Darwin Hospital NT 4 Urban Waiver 287 Royal Hobart Hospital TAS 1 Urban Waiver 87 Royal Melbourne Hospital VIC 25 Urban Waiver 483 Royal North Shore Hospital NSW 2 Urban Opt-out 225 Royal Prince Alfred Hospital NSW 1 Urban Waiver 223 Sir Charles Gairdner Hospital WA 6 Urban Opt-out 362 St George Hospital NSW 1 Urban Waiver 213 St Vincent’s Hospital, Melbourne VIC 6 Urban Waiver 225 Tamworth Hospital NSW 3 Rural Waiver 74 The Alfred Hospital VIC 2 Urban Opt-out 237 The Canberra Hospital ACT 8 Urban Waiver 259 Toowoomba Hospital QLD 3 Regional Waiver 81 Western Health VIC 3 Urban Waiver 231 Western Sydney Local Health District (including Westmead, Auburn and NSW 0 Urban Opt-out 320 Blacktown Hospitals) Wollongong Hospital NSW 4 Regional Waiver 170
*Urban was defined as being located in an area with a population of 100,000 and over. All other services were categorised as regional/rural. 16
Table 2 – Trial outcomes
Primary outcome Definition
Dialysis catheter related One of the following – bacteremia per 1000 catheter days • Culture of the same organism from both the catheter tip AND at least one percutaneous blood culture; • OR culture of the same organism from at least two blood samples (one from a catheter hub and the other from a peripheral vein • OR bacteremia in the absence of another source.
Secondary outcomes
Suspected or possible catheter Catheter removal for the reason of suspected infection with related bacteremia negative blood cultures
Total suspected and possible Catheter removal for the reason of suspected infection with bacteremia positive or negative blood cultures
17
Table 3 – Participant characteristics of all participants with data entered during the baseline phase . Patient Characteristics n (%) (n=3615 (%))
Males 2174 (60.1) Age (Median, IQR) years 63.0 (50-73) Ethnicity/ Ancestry Asian (including Chinese, Malay, Filipino, Vietnamese, Indonesian) 292 (8.1) Indigenous Australian (including Aboriginal & Torres Strait Islander) 350 (9.7) Caucasian 2331 (64.5) Māori 31 (0.9) Pacific Islander (including Tongan, Samoan and Cook Islander) 91 (2.5) Other 112 (3.1) Medical records did not indicate ethnicity/ancestry 408 (11.3) State of enrolment ACT 96 (2.7) NSW 1232 (34.1) QLD 877 (24.3) NT 194 (5.4) SA 245 (6.8) VIC 758 (21.1) WA 165 (4.6) TAS 48 (1.3) Location of Enrolling Renal service Urban 3111 (86.1) Regional/Rural 504 (13.9) Diabetes Mellitus- Yes, diet controlled 309 (8.6 %) Yes, medication controlled 1268 (35.1 %) Immunosuppressant use 477 (13.2%)
18
Table 4 – Reasons for Catheter Insertion
Reason for CVC Insertion N=5385 (100%)
AKI 1896 (35.0%)
Initiation of maintenance dialysis with no 1703 (31.6%) functioning access
Transfer from peritoneal dialysis 632 (11.7%)
AVF/AVG Problems 706 (13.1%)
Other 446 (8.3%)
19
Figure 1 – Trial timelines
20
Figure 2 – Interventions Information sheet
REDUCCTION Investigator team- Site staff list for publications
Site First name Last name Alice Springs Hospital Senthil Kumar Balakrishnan Alice Springs Hospital David Fernandes Armadale Hospital Hemant Kulkarni Armadale Hospital Casey Light Armadale Hospital Jo Ryan Auckland Hospital Emma Marsh Auckland Hospital Jason Wei Auckland Hospital David Semple Austin Hospital Vilma Lleva Austin Hospital Lucy Mwangi Austin Hospital Peter Mount Austin Hospital Maree Ross-Smith Austin Hospital Marieke Veenendaal Barwon Health Vicki Smith Barwon Health Christine Somerville Cairns Hospital Shaun Davidson-West Cairns Hospital Natalie Grainer Cairns Hospital Stella Green Cairns Hospital Murty Mantha Cairns Hospital Kati Thiessen Canberra Hospital Girish Talaulikar Canberra Hospital Alison Winsbury Canberra Hospital Irene Yao Canberra Hospital Emily Neville Concord Hospital Khalilah Marquez Concord Hospital Mona Razavian Concord Hospital Lisa Tienstra Concord Hospital Glenn Stewart Eastern Health Cathy Chan Eastern Health Peta McLean Eastern Health Lawrence McMahon Eastern Health Matthew Roberts Fiona Stanley Hospital Monika Chang Fiona Stanley Hospital Anna Chiam Fiona Stanley Hospital Duncan Wright Fiona Stanley Hospital Samadhi Wimalasena Fiona Stanley Hospital Orla O'Brien Fiona Stanley Hospital Ramyasuda Swaminathan Fiona Stanley Hospital Chan Wing Fiona Stanley Hospital Lorraine Ansell Fiona Stanley Hospital Samadhi Wimalasena Fiona Stanley Hospital Harish Puttagunta Flinders Medical Centre Jeffrey Barbara Flinders Medical Centre Amanda Luke
REDUCCTION Publications listing V4.0 dated 13-Mar-2020 Page 1 of 4
Site First name Last name Flinders Medical Centre Margaret Pummeroy Flinders Medical Centre Kim Torpey Gold Coast Hospital and Health Service Gemma Nicholls Gold Coast Hospital and Health Service Amy Swinbank Gold Coast Hospital and Health Service Thomas Titus John Hunter Hospital Peter Choi John Hunter Hospital Ginger Chu John Hunter Hospital Leanne Garvey John Hunter Hospital Alastair Gillies Liverpool Hospital Josephine Chow Liverpool Hospital Imelda De Guzman Liverpool Hospital Jeanny Gando Liverpool Hospital Jeffrey Wong Liverpool Hospital Richard Nguyen Mackay Hospital Roy Cherian Mackay Hospital Raye Gillard Mackay Hospital Rachel James Mater Hospital Michael Burke Mater Hospital Leanne Glancy Mater Hospital Shimbie Lewis Mater Hospital Dr Richard Baer Mater Hospital Sophie Wade Middlemore Hospital Daniel Lin Middlemore Hospital Fortune Ngwenya Middlemore Hospital Anupkumar Narayanankutty Monash Health Kate Fitt Monash Health Peter Kerr Monash Health Prof Kevan Polkinghorne Monash Health Mechelle Seneviratne Sunshine Coast Hospital and Health Service Nicholas Gray Sunshine Coast Hospital and Health Service Gerald Hilder Sunshine Coast Hospital and Health Service Kaylene Wadd Sunshine Coast Hospital and Health Service Andrea Pollock Sunshine Coast Hospital and Health Service Stanley Searle Nepean Hospital Muralikrishna Komala Nepean Hospital Junie McCourt Nepean Hospital Craig Lawlor Ipswich Hospital Julia Bell Ipswich Hospital David W Johnson Prince of Wales Hospital Michaela Kelleher Prince of Wales Hospital Debbie Knagge Prince of Wales Hospital Sradha Kotwal Metro South Hospital and Health Service Amanda Coburn Metro South Hospital and Health Service Sarah Guo Metro South Hospital and Health Service David W Johnson
REDUCCTION Publications listing V4.0 dated 13-Mar-2020 Page 2 of 4
Site First name Last name Metro South Hospital and Health Service Joanna Sudak Metro South Hospital and Health Service Diana Leary Rockhampton Hospital Jenny Anderson Rockhampton Hospital Thin Han Rockhampton Hospital Tresna Titmarsh Rockhampton Hospital Leticia Spann Royal Adelaide Hospital Emily Adam Royal Adelaide Hospital Bronwyn Hockley Royal Adelaide Hospital Jenny Latte Royal Adelaide Hospital Yvonne Matthew Royal Adelaide Hospital Stephen McDonald Royal Adelaide Hospital Chen Au Peh Royal Adelaide Hospital Rebecca Taylor Royal Brisbane Hospital David McIntyre Royal Brisbane Hospital Sharadchandra Ratanjee Royal Darwin Hospital Karolynn Maurice Royal Darwin Hospital Fiona Rettie Royal Darwin Hospital Madhivanan Sundaram Royal Darwin Hospital Naomi Grimshaw Royal Hobart Hospital Matthew Jose Royal Hobart Hospital Gail Read Royal Melbourne Hospital Jayne Amy Royal Melbourne Hospital Patricia Coutts Royal Melbourne Hospital Maria Presno Royal Melbourne Hospital Nigel Toussaint Royal North Shore Hospital Debbie Knagge Royal North Shore Hospital Colleen Van Senden Royal North Shore Hospital Linh Pham Royal North Shore Hospital Muh Geot Wong Royal Prince Alfred Hospital Jane Nicholson Royal Prince Alfred Hospital Paul Snelling Sir Charles Gairdner Hospital Neil Boudville Sir Charles Gairdner Hospital Alison Farmer Sir Charles Gairdner Hospital Ingrid Holmes Sir Charles Gairdner Hospital Victoria Link Sir Charles Gairdner Hospital Vivien Perreau Sir Charles Gairdner Hospital Nicole Warnecke St George Hospital Sunil Badve St George Hospital Yanella Martinez-Smith St George Hospital Jayson Catiwa St Vincent's Hospital Frank Ierino St Vincent's Hospital Emmet O'flaherty Tamworth Hospital Stephen May Tamworth Hospital Cheryl Wertheim Tamworth Hospital Jill Telfer
REDUCCTION Publications listing V4.0 dated 13-Mar-2020 Page 3 of 4
Site First name Last name The Alfred Hospital Omar Tombocon The Alfred Hospital Rowan Walker The Alfred Hospital Anne Weston The Alfred Hospital Scott Wilson The George Institute for Global Health Benjamin Talbot Toowoomba Hospital Elizabeth Coroneos Toowoomba Hospital Shannon Nugent Toowoomba Hospital Ian Fox Toowoomba Hospital Sree Venuthurupalli Waikato Hospital Helen O'Connell Waikato Hospital Deborah Peek Waikato Hospital Kannaiyan Rabindranath Waikato Hospital Christine Torrie Waikato Hospital Tania Smith Waikato Hospital Andrew Henderson Waitemata DHB Naveed Ahmed Waitemata DHB Vinish Thekkoot Vasudevan Wellington Hospital Grant Pidgeon Western Health Jennifer Connor Western Health Ruth Thachaw Western Health Sandra Crikis Whangarei Hospital Lynda Cumming Whangarei Hospital Walaa Saweirs Whangarei Hospital William (Billy) Stewart Whangarei Hospital Sharen Supershad Wollongong Hospital Pauline Byrne Wollongong Hospital Karumathil Murali Wollongong Hospital Hicham Cheikh Hassan Wollongong Hospital Elizabeth Fleming WSLHD - Auburn Hospital Lin Huang WSLHD - Blacktown Hospital Romiereeza Dizon WSLHD - Blacktown Hospital Deepika Joshi WSLHD - Blacktown Hospital Jon Mendoza WSLHD - Westmead Hospital Bishi Augustine WSLHD - Westmead Hospital Disha Balraj WSLHD - Westmead Hospital Vincent Lee WSLHD - Westmead Hospital David O'Donnell WSLHD - Westmead Hospital Khin Myint
Other contributing partner organisations
Organisation name ANZDATA Registry Department of Health and Human Services Victoria – Safer Care Victoria Kidney Health Australia
REDUCCTION Publications listing V4.0 dated 13-Mar-2020 Page 4 of 4
Kidney Health Australia- Caring for Australasians with Renal Impairment Queensland Health
REDUCCTION Publications listing V4.0 dated 13-Mar-2020 Page 5 of 4 Supplemental Materials
Table 1 – Ethics committee and services covered
Table 2 – Allocation schedule
Table 3 - Data collected in the trial/CRF
Table 4 – New questions added in the intervention phase
Table 1 – Ethics committee and services covered
Ethics committee Approval number Services covered
Austin Health; Cairns Hospital; Sydney Local Health District HREC/16/CRGH/76 Concord Hospital; Eastern CRGH Human Research Ethics Health; Flinders Medical Committee (HREC) Centre; Geelong Hospital (Barwon Health); Gold Coast Hospital and Health Service; John Hunter Hospital; Liverpool Hospital; Mackay Hospital; Monash Health; Sunshine Coast University Hospital and Health Service; Nepean Hospital; Prince of Wales Hospital; Metro South Hospital and Health Service (including Princess Alexandria Hospital, Redlands and Logan Hospital); Rockhampton; Royal Adelaide Hospital; Royal Brisbane Hospital; Royal Melbourne Hospital; Royal North Shore Hospital; Royal Prince Alfred Hospital; St George Hospital; St Vincent’s Hospital, Melbourne; Tamworth Hospital; The Alfred Hospital; Toowoomba Hospital; Western Health; Western Sydney Local Health District (including Westmead, Auburn and Blacktown Hospitals); Wollongong Hospital.
Central Australia HREC HREC-16-420 Alice Springs Hospital
HREC of the Northern Territory HREC/2016-2660 Royal Darwin Hospital Department of Health and Menzies School of Health Research
Royal Perth Hospital HREC HREC 2016-154 Armadale Health Service, Fiona Stanley Hospital, Sir Charles Gairdner Hospital
The University of Tasmania H0015890 Royal Hobart Hospital HREC
Mater Misericordiae Ltd HREC HREC/17/MHS/99 Mater Hospital, Brisbane
Australian Capital Territory HREC/17/MHS/99 The Canberra Hospital and Health HREC Health Service
Table 2 – Allocation schedule
Allocation schedule Number of services Mean number of catheters
Treatment/Treatment/Treatment 12 78.7
Control/Treatment/Treatment 12 79.7
Control/Control/Treatment 13 86.7
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Demographic data*
1. Has the patient been I__I Yes given the REDUCCTION I__I No (No data entry allowed unless yes elected in Q1) participant information sheet and not opted out I__I N/A (For waiver of consent sites only) of the study?
2. Patient details First name: …………………………. Middle: ………………………….
Last name: …………………………. MRN: ………………………….
3. Date of birth |__|__| / |__|__| / |__I__|__|__| DD/MM/YYYY
Country of birth: I__I Australia I__I New Zealand
I__I Other- please specify: …………………………...
If in Australia- State of residence:
I__I NSW I__I ACT I__I VIC I__I QLD I__I SA I__I WA I__I NT
4. Gender I__I Male
I__I Female I__I Other
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
5. Patient race I__I Asian- (including Chinese, Indian, Malay, Filipino, Vietnamese, Indonesian)
I__I Caucasian
I__I Indigenous Australian (including Aboriginal & Torres Strait Islander) I__I Maori I__I Pacific islander (including Tongan, Samoan and Cook Islander)
I__I Other (specify) I__I Medical records do not indicate patient race
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Medical History*
1. Does the patient have I__I Yes (Diet controlled) Diabetes (defined as I__I Yes Medication controlled requiring dietary treatment, oral I__I No hypoglycaemic medication and/or insulin)?
2. Is the patient on any I__I Yes I__I No immunosuppressant
medication? * (I.e: oral prednisone, cyclosporine, tacrolimus, azathioprine, hydroxychloroquine We will provide detailed list in the data dictionary etc)
Participant
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Pre-Intervention form Catheter Insertion
1. Is this a new catheter I__I Yes- new catheter insertion?* I__I No- re-wire
2. Date catheter Inserted* |__|__| / |__|__| / |__I__|__|__| (DD/MM/YYYY) ALERT: If the date of line insertion is within 48 hours of previous catheter removal proceed to Q3. If not within 48 hours, go to Q4.
I__I Not known
3. Date renal unit assumed care |__|__| / |__|__| / |__I__|__|__| of patient*
(DD/MM/YYYY) To default to date in Q3
4. Is this catheter a I__I Yes replacement for the previous I__I No catheter that was removed on DD/MM/YYYY (pre- populated with catheter removal date)
5. Catheter insertion site* I__I Left side of body I__I Right side of body
6. Vein of insertion* I__I Subclavian I__I Internal Jugular
I__I Femoral I__I Other: specify …………………………………………………….
7. Catheter Type* I__I Tunnelled (proceed to Q7) I__I Non-tunnelled (proceed to Q10)
8. Catheter Brand I__I Baxter Types of tunnelled catheter produced by this brand- TBC
I__I Gambro
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
I__I Medcomp
I__I Arrow
I__I Bard
I__I Palindrome
I__I Tesio
I__I Other: specify …………
I__I Not known
9. Blood flow rate (ml/min) I__I <200 I__I 350-399 I__I 200-240 I__I 400+
Maximum blood flow rate I__I 250-299 I__I Not known achieved on first dialysis I__I 301-349
10. Hospital location of catheter I__I Operating theatre insertion* I__I Radiology
I__I ICU
I__I Renal Ward/ Dialysis unit I__I Emergency Department I__I Other
11. Who inserted the catheter?* I__I Renal Unit staff I__I Interventional Radiology
I__I ICU staff I__I Anaesthetics I__I Surgical staff
I__I Other
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
12. Reason for dialysis requiring I__I Acute Kidney Injury (proceed to Q16 /form complete) central venous access* I__I Commencement of maintenance dialysis without functioning access (proceed to Q13)
I__I Transfer from Peritoneal Dialysis (temporary or permanent) (proceed to Q15 /form complete)
I__I Fistula thrombosis (proceed to Q16 /form complete) I__I Fistula infection (proceed to Q16 /form complete) I__I Graft thrombosis (proceed to Q16 /form complete)
I__I Graft infection (proceed to Q16 /form complete) I__I Other: specify …………………………………………………….
13. For commencement of What is the patients I__I New to any service (initial presentation dialysis without functioning relationship to a Renal within last 3 months) access patients only (2nd Service (includes other I__I New to any service (initial presentation option in Q12)* Renal services outside of within last 3-6 months) study site) I__I Known to a renal service (patient seen within last 6 months) I__I Known to a renal service, lost to follow up (not seen within last 6 months) I__I Known to a renal service but has repeatedly refused access creation (within last 6 months)
14. For commencement of Has the patient I__I Yes (proceed to Q15) dialysis without functioning undergone attempts at I__I No (form complete) access patients only (2nd access creation (including option in Q12)* for peritoneal dialysis) prior to catheter insertion? Proceed to Q16/form complete
15. (To be answered only if How many attempts? I__I once Q14=yes) I__I twice or more
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Ongoing Interventions (within catheter period)*
1. Has the patient undergone I__I Yes any dialysis access related I__I No (proceed to Q4/ form complete) procedures (surgical or otherwise) within the life of this catheter?
2. Date of procedure |__|__| / |__|__| / |__I__|__|__| DD/MM/YYYY
3 Procedure type I__I Re-suturing of catheter I__I Thrombolysis to restore catheter patency (not as regular lock)
I__I Creation of new AV fistula I__I Creation of new AV Graft I__I Insertion of new PD catheter
I__I Revision of existing AV fistula or AV Graft I__I Thrombectomy +/- Angioplasty to a AV Fistula or AV Graft I__I Other: specify …………………………………………………….
Infectious Events*
1. Have there been any I__I Yes catheter related infectious I__I No (If no proceed to Q10) events during the life of this catheter?
2. Date of catheter related |__|__| / |__|__| / |__I__|__|__| infection onset
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
3. Type of catheter related I__I Proven catheter related bacteraemia infection? I__I Suspected catheter related bacteraemia (pending TGI adjudication)
I__I Suspected catheter related bacteraemia (TGI adjudication confirmed) If suspected please provide I__I Tunnel related infectious event details to TGI I__I Exit site infection I__I Other: specify……………………….. More than one option can be elected
4. Were blood cultures taken I__I Yes (proceed to Q5) within 7 days of the I__I No (If no proceed to Question 9) infectious event?
5. 5a. Date blood cultures |__|__| / |__|__| / |__I__|__|__| taken within 7 days of the onset of infectious event (if more than one culture was taken, then record either the positive result or the one closest in time to the onset of the infectious event)
5b. Blood culture result I__I culture positive I__I culture negative (proceed to Q6)
5c. Type of Organism I__I Staph aureus cultured I__I Staph epidermidis
I__I Escherichia coli I__I Klebsiella pneumonia I__I MRSA (sensitive or resistant)
I__I other: specify………………………..
6. Was the catheter tip sent for I__I Yes (proceed to Q7) culture analysis? I__I No, tip was not sent (proceed to Q8) I__I No, catheter was not removed (proceed to Q8) Additional question triggered in catheter removal page (Q2)
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
7. 7a. Date of catheter tip |__|__| / |__|__| / |__I__|__|__| analysis
7b. Analysis result I__I culture positive
I__I culture negative (proceed to Q8)
7c. Type of Organism I__I Staph aureus cultured I__I Staph epidermidis I__I Escherichia coli I__I Klebsiella pneumonia
I__I MRSA (sensitive or resistant) I__I other: specify………………………..
8. Were any swabs from the I__I Yes (proceed to Q9) insertion site analysed? I__I No (proceed to Q10) (Report results for the swabs closest to the time of the infectious event)
9. 9a. Date of swab analysis |__|__| / |__|__| / |__I__|__|__|
9b. Analysis result I__I culture positive I__I culture negative (proceed to Question 10)
9c. Type of Organism I__I Staph aureus cultured I__I Staph epidermidis I__I Escherichia coli
I__I Klebsiella pneumonia I__I MRSA (sensitive or resistant) I__I other: specify………………………..
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Catheter removal*
1. Has the participant’s I__I Yes (proceed to Q4) catheter been removed? I__I No (proceed to Q2/3)
Choose yes if it has been removed or is no longer under the care of the renal unit e.g. transferred to a non-REDUCCTION site
2. Why was the catheter not I__I No options for replacement of catheter removed? I__I Good response to antibiotic treatment To be answered only if I__I Poor peripheral access Infection form specifies that infectious event has I__I Other: specify……………………….. occurred.
3. Is there an intent to create I__I Yes (Form complete. Further follow up to be triggered in 2 weeks) non-catheter dialysis access I__I No (Form complete. Further follow up to be triggered in 4 weeks) in this patient?
4. Date catheter removed |__|__| / |__|__| / |__I__|__|__|
5. What was the primary I__I No Longer Required reason for this catheter’s I__I Poor flow removal I__I Extruded cuff I__I Local infection
I__I Proven sepsis I__I Suspected sepsis I__I Changed catheter site/type to reduce complication risk
I__I Patient discharge from our service I__I Patient death with catheter in-situ (Link to death page) I__I Patient transferred to non-REDUCCTION renal unit
I__I Other: specify …………………………………………………….
6. Was the catheter replaced? I__I Yes (if yes, link to new catheter insertion form)
I__I No
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
7. What was the primary I__I Recovery of Renal Function reason that this catheter was I__I Functional Haemodialysis access (AVF or AVG) not replaced? I__I Functional Peritoneal dialysis access I__I Withdrew from treatment
I__I Transplant I__I Death (proceed to death page) I__I Other: specify …………………………………………………….
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Participant Outcome (death)
1. Date of death* |__|__| / |__|__| / |__I__|__|__|
2. Cause of death I__I Cardiovascular (proceed to Q4/ form complete)
I__I Infection (If elected proceed to Q3). I__I Cancer (proceed to Q4/ form complete) I__I Other: specify ……………………………………………………. (proceed to Q4/ form complete)
3. (Only to be answered if Q3= Did the caring physician deem I__I Yes Infection) infection from the catheter as the I__I No cause of death?
4. Date of data entry |__|__| / |__|__| / |__I__|__|__|
5. Data completed by …………………………………………………………………………….
Adverse Events
1. Has the participant I__I Yes experienced any adverse I__I No (form complete) events (which are viewed as probably related to the study intervention)?*
2. Date of adverse event onset |__|__| / |__|__| / |__I__|__|__|
3. Event type I__I Allergy/Skin reaction
I__I Catheter damage I__I Resistant organisms I__I Other: specify ………………………………………………………
4 Describe event ………………………………………………………………………………
5. Event outcome I__I Ongoing (skip to Q7. Re-triggered until Q5 outcome resolved). I__I Resolved I__I Resolved with sequelae
6. Date of event resolution |__|__| / |__|__| / |__I__|__|__|
7. Date of data entry |__|__| / |__|__| / |__I__|__|__|
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Catheter removal*
1. Has the patient’s catheter I_1_I Yes (proceed to Q3) been removed? I_2_I No, patient discharged from our service: (proceed to Q2)
I__I Will complete later
2. Is the patient being Date of transfer: |__|__| / |__|__| / |__I__|__|__| discharged to another
participating REDUCCTION Renal unit? I_1_I Yes
More information: If you are I_2_I No unsure whether the unit is part of the REDUCCTION study, please refer to the Site name: ……………...(both options must complete free text entry) REDUCCTION Site Directory or contact the study team for advice.
3. Date catheter removed |__|__| / |__|__| / |__I__|__|__| I__I Will complete later
4. Please specify the last I__I Semi-permeable, transparent dressing dressing type used on this I__I Chlorhexidine impregnated patch catheter prior to removal I__I Chlorhexidine impregnated sponge I__I Alternative dressing (semi-permeable dressing not suitable for patient)
|__| No dressing
5. Was an antimicrobial locking I__I Yes, anti-microbial citrate based lock solution used when this I__I Yes, anti-microbial taurolidine based lock catheter was last accessed prior to its removal? I__I Yes, anti-bacterial locking solutions (e.g. Gentamicin) I__I No
|__| Will complete later
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
6. What was the primary I_1_I No Longer Required reason for the removal of I_2_I Poor flow this catheter? I_3_I Extruded cuff I_4_I Local infection
I_5_I Confirmed sepsis I_6_I Possible sepsis I_7_I Changed catheter site/type to reduce complication risk
I_8_I Patient discharge from our service I_9_I Patient death with catheter in-situ (Link to death page Q1 + skip Removals Q6 and 7) I_11_I Other: specify..………………………………………………….
7. Was the catheter replaced? I_1_I Yes (go to question 7) I_2_I No (go to question 8)
8. Was this catheter re-wired? I_1_I Yes (link to new catheter insertion page) I_2_I No (link to new catheter insertion page)
9. What was the primary I_1_I Recovery of renal function reason that this catheter was I_2_I Functional Haemodialysis access (AVF or AVG) not replaced? I_3_I Functional Peritoneal dialysis access
I_4_I Withdrew from treatment I_5_I Transplant I_6_I Death (proceed to death page)
I_7_I Other: specify ……………………………………………………. I_8_I Will complete later
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Post-Intervention Additional Questions Catheter Insertion
1. Type of antiseptic solution I__I ≥2% chlorhexidine with 70% alcohol used during insertion I__I povidone-iodine
I__I 70% alcohol
I__I Other: specify …………………………………………………….
|__| Not known
|__| Will complete later
2. Was an ultrasound device I__I Yes used TO GUIDE catheter I__I No insertion? |__| Not known |__| Will complete later
3. Type of dressing used at I__I Semi-permeable, transparent dressing insertion I__I Chlorhexidine impregnated patch
I__I Chlorhexidine impregnated sponge I__I Alternative dressing (semi-permeable dressing not suitable for patient)
|__| No dressing |__| Will complete later
4. Will an antimicrobial I__I Yes, anti-microbial citrate based lock locking solution be used I__I Yes, anti-microbial taurolidine based lock on this catheter? I__I Yes, anti-bacterial locking solutions (e.g. Gentamicin) I__I No |__| Will complete later
18. Was the patient given the I__I Yes REDUCCTION catheter I__I NoI__I NA (NZ sites only) care sheet within 24 hours of catheter insertion? If no, Please provide reason:………………………………………………
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
Catheter Maintenance (To pop up when a catheter has been active for more than 28 days
1. Type of catheter dressing currently utilised I__I Semi-permeable, transparent dressing on this catheter I__I Chlorhexidine impregnated patch
I__I Chlorhexidine impregnated sponge I__I Alternative dressing (semi-permeable dressing not suitable for patient) |__| No dressing
2. Is an antimicrobial locking solution currently I__I Yes, anti-microbial citrate based lock being used on this catheter? I__I Yes, anti-microbial taurolidine based lock
I__I Yes, anti-bacterial locking solutions (e.g. Gentamicin)
I__I No |__| Will complete later
3. What plan is in place at 28 days for future I__I Expecting recovery of renal function (and no need for dialysis access? permanent access) I__I Expecting to use existing dialysis access after recovery/maturation
I__I Surgery for permanent access creation is planned I__I Planned for permanent dialysis catheter use
I__I No current plan I__I Other: specify:……………………………………
Catheter removal*
1. Please specify the last I__I Semi-permeable, transparent dressing dressing type used on this I__I Chlorhexidine impregnated patch catheter prior to removal I__I Chlorhexidine impregnated sponge I__I Alternative dressing (semi-permeable dressing not suitable for patient) |__| No dressing
Site Number: I__I__I__I REDUCCTION CASE REPORT FORM
Subject Number: I__I__I__I__I__I__I
2. Was an antimicrobial locking I__I Yes, anti-microbial citrate based lock solution used when this I__I Yes, anti-microbial taurolidine based lock catheter was last accessed prior to its removal? I__I Yes, anti-bacterial locking solutions (e.g. Gentamicin) I__I No |__| Will complete later
Adverse Events
1. Date of adverse event onset |__|__| / |__|__| / |__I__|__|__|
2. Event type I_1_I Allergy/Skin reaction I_2_I Catheter damage I_3_I Resistant organisms
I_4_I Other: specify………………………………………………………
3. Describe event ………………………………………………………………………………
4. Event outcome I_1_I Ongoing (skip to Q7. Page not complete until options 2 or 3 elected) I_2_I Resolved
I_3_I Resolved with sequelae
5.. Date of event resolution |__|__| / |__|__| / |__I__|__|__|
6. Does the Investigator believe I_1_I Yes that this adverse event was I_2_I No reasonably related to a component of the REDUCCTION study Intervention? If yes, specify which component: ………………………………………………………………………………