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Colloid Starches (Volume Expanders) TITLE: Hydroxyethyl Starch versus Other Plasma Volume Expanders: A Review of the Clinical and Cost-Effectiveness, and Guidelines for Use DATE: 23 May 2013 CONTEXT AND POLICY ISSUES Fluid resuscitation is indicated for the management of hypovolemia (decreased blood plasma volume) and hypovolemic shock,1 and its ultimate objective is to restore organ perfusion and tissue oxygenation.2 Hypovolemia can be induced by a wide range of clinical conditions such as dehydration, burns, sepsis, malignancies, trauma, hemorrhage, and surgical anesthesia. Clinical signs of hypovolemia include blood pressure, urine output, mental status, and peripheral perfusion.1 There are two main types of fluids used for fluid resuscitation, colloids and crystalloids. Crystalloid solutions include normal saline and balanced fluids such as Ringer’s lactate.3 Human albumin preparations are natural colloids while dextran, gelatin, and starch products are synthetic colloids, also called synthetic plasma volume expanders.3 Hydroxyethyl starches are a common choice for fluid resuscitation.4 They are preferred over albumin because of their relatively lower price.5 These starches are supplied with different molecular weights ranging from 120 kDa to >450kDa. They are also characterized by the degree of substitution which is the molar substitution by hydroxyethyl groups. The degree of substitution ranges from 0.4 to 0.7. It is believed that the molecular weight and degree of substitution can affect patient outcomes.6 Four hydroxyethyl starches are available in Canada; these are Volvulen, Volulyte, Pentaspan and Hextend. Characteristics of these solutions are presented in Table 1. Table 1. Characteristics of the Hydroxyethyl Starch Solutions Available in Canada Type of Molecular Degree of Maximum Solution Solvent/ medium Tonicity starch weight (kda) substitution dose Volvulen Tetrastarch 130 0.4 Isotonic electrolyte 6% 50 ml/kg/day Volulyte Tetrasarch 130 0.4 0.9% NaCl 6% 33 ml/kg/day Pentaspan Pentastarch 200-300 0.4-0.5 0.9% NaCl 10% 28 ml/kg/day Hextend Hexastarch 450-800 0.75 Lactate electrolyte 6% 20 ml/kg/day Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by email or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. The use of hydroxyethyl starches for fluid resuscitation is undergoing a comprehensive review.7 Results from recent randomized controlled trials suggest that these starches may be associated with increased risk of bleeding, renal dysfunction and mortality.7 However, results from these RCTs were not consistent; some RCTs such as the CRYSTMAS trial reported that HES did not differ from normal saline in terms of adverse events,8 while the 6S and VISEP trials reported that HES was associated with increased mortality and kidney injury.9,10 On the other hand, CHEST trial evaluated almost 7000 ICU patients who were resuscitated with HES or saline. The trial concluded that HES, compared to saline, was not associated with a significant increase in mortality, but it increased the incidence of renal replacement therapy.11,12 The evaluation of HES was further complicated by the retraction from the peer-reviewed literature of the studies published by Boldt and co-workers.11,13. Given these issues, the appropriate use of HES for fluid resuscitation remains unclear. The objective of the current review is to evaluate the evidence surrounding the use of hydroxyethyl starch in intensive-care units. RESEARCH QUESTIONS 1. What is the clinical effectiveness of hydroxyethyl starch compared with other plasma volume expanders for use in patients in the intensive care unit? 2. What are the guidelines regarding the use of hydroxyethyl starch as a volume expander for patients in the intensive care unit? 3. What is the cost-effectiveness of hydroxyethyl starch used as a volume expander for patients in the intensive care unit? KEY FINDINGS Twelve meta-analyses, two clinical guidelines, and one cost-effectiveness study were included in the review. The available evidence indicates the use of hydroxyethyl starch is associated with increased risk of mortality and renal dysfunction when used for fluid resuscitation in critically ill patients and patients with severe sepsis. The available evidence suggests that the use of hydroxyethyl starch in patients undergoing surgery may be associated with increased risk of bleeding and reoperation due to bleeding. One cost-effectiveness analysis showed that hydroxyethyl starches were less cost-effective, compared with albumin, when used for fluid resuscitation in sepsis patients. Hydroxyethyl Starch versus Other Plasma Volume Expanders 2 METHODS Literature Search Strategy A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2013, Issue 4), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between Jan 1, 2010 and Apr 24, 2013. Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed for relevance. Full texts of any relevant titles/abstracts were retrieved, and assessed for inclusion. The final article selection was based on the inclusion criteria presented in Table 2. Table 2 : Selection Criteria Patients who need fluid replacement treated in intensive care unit, Population and patients who could be considered as intensive care (e.g., trauma, post-surgery) Intervention Hydroxyethyl starch (HES), a colloidal starch Crystalloid solutions (e.g., saline, Ringer’s lactate) Comparator Albumin Q1: comparative clinical effectiveness (benefits, harms, safety) Outcomes Q2: evidence-based guidelines Q3: cost-effectiveness, comparative or not Systematic reviews, meta-analyses, health technology assessments Study Designs and cost-effectiveness studies Exclusion Criteria Systematic reviews and meta-analyses were excluded if they included primary trials conducted on healthy volunteer and of stable patients with chronic diseases. An additional exclusion criteria for systematic reviews was the inclusion of uncontrolled trials and observational studies. This was justified by the abundance of RCTs evaluating HES in different medical contexts; a scoping literature search detected more than 70 RCTs published between 2008 and 2013. Therefore, the inclusion of systematic reviews with uncontrolled trials or observational studies would have compromised the quality of evidence without additional value in terms of information quantity. Furthermore, reviews were excluded if they did not evaluate HES specifically i.e., reviews on colloids without specifying HES as a separate subgroup. Hydroxyethyl Starch versus Other Plasma Volume Expanders 3 Systematic reviews or guidelines with a more recent update were be considered duplicates and were excluded; the most recent update will be considered the primary publication, and previous versions were used as secondary source of data. Critical Appraisal of Individual Studies Critical appraisal of the included studies was based on study design. The Appraisal of Guidelines Research and Evaluation (AGREE) instrument14 was used to evaluate the quality of the included guideline. The methodological quality of the included systematic reviews and meta-analyses was evaluated using the “assessment of multiple systematic reviews” (AMSTAR).15 AMSTAR is an 11-item checklist that has been developed to ensure reliability and construct validity of systematic reviews. The methodological quality of the included cost-effectiveness study was assessed using the
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