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A Systematic Review of the Comparative Safety of Colloids

A Systematic Review of the Comparative Safety of Colloids Abstract Hypothesis Safety differences exist among colloids widely used for fluid management in acutely ill patients, as judged according to the comparative incidence of adverse events. Data Sources Colloid safety data for human subjects were sought, without language or time period restrictions, by means of computer searches of bibliographic and clinical trial databases, hand searches of medical journals and Index Medicus, inquiries with investigators and colloid suppliers, and examination of reference lists. Search terms included "colloids", "morbidity", and "mortality". Study Selection Controlled trials, cohort studies, pharmacovigilance studies, and prior meta-analyses were independently selected by 2 unblinded investigators. Of 189 candidate studies, 113 were included, with safety data encompassing 1.54 × 106 patients and 1.09 × 108 colloid infusions. Data Extraction Two unblinded investigators independently extracted data. Study limitations and confounding factors were tabulated. Data Synthesis With albumin as the reference colloid, the incidence rate ratio for anaphylactoid reactions was 4.51 (95% confidence interval, 2.06-9.89) after hydroxyethyl starch administration, 2.32 (95% confidence interval, 1.21-4.45) after dextran, and 12.4 (95% confidence interval, 6.40-24.0) after gelatin. Pruritus occurrence was significantly increased by hydroxyethyl starch exposure (odds ratio, 1.78; 95% confidence interval, 1.23-2.58). Artificial colloid administration was consistently associated with coagulopathy and clinical bleeding, most frequently in cardiac surgery patients receiving hydroxyethyl starch. On the basis of large-scale pharmacovigilance study results, albumin infusion resulted in a low rate of both total adverse events (3.1 to 8.6 per 105 infusions) and serious adverse events (1.29 per 106 infusions). Conclusions Significant safety differences exist among colloids. Therefore, conclusions regarding the clinical usefulness of colloids as a fluid class should be formed with caution. Colloids promote retention of fluid in the intravascular space, with concomitant reduction of the potential for edema that might compromise the function of organs such as the lungs, myocardium, and gastrointestinal tract.1 The chief colloids currently in routine clinical use worldwide are albumin, hydroxyethyl starch (HES), dextran, and gelatin. Clinically available albumin is a 69-kDa protein purified from human plasma. Hydroxyethyl starch is synthesized by partial hydrolysis of amylopectin plant starch and hydroxyethylation at the C2, C3, and C6 positions of the constituent glucose molecules. Dextran is composed of naturally occurring glucose polymers synthesized by Leuconostoc mesenteroides bacteria growing in sucrose-containing media. Gelatin for clinical use is derived from hydrolysis of bovine collagen followed by being either succinylated or linked to urea. All 3 artificial colloids are polydisperse molecules in a range of sizes. Hydroxyethyl starch is clinically available in an array of forms differing on the basis both of average molecular weight and extent of molar substitution, although in the United States only the HES of high molecular weight (450 kDa) of 0.7 molar substitution ratio has been used in routine fluid management. In the United States, dextran is less extensively used for fluid management than is HES, and gelatin is unavailable for clinical use. Clinically available colloids have generally exhibited similar effectiveness in maintaining colloid oncotic pressure. Thus, colloids have often been viewed as a class of essentially interchangeable inert fluids, and selection of colloid has commonly been based on cost and convenience. Nevertheless, differences in safety profiles among colloids are well recognized.2,3 Such differences underlie, for example, the recommended 1500 mL (20 mL per kilogram of body weight) dose limitation for HES.4 The clinical importance of differences in colloid safety has been debated. Firm conclusions have been difficult to draw, in part because comparative colloid safety has not been systematically reviewed. We here present the results of such a review. Methods Inclusion criteria We systematically sought all studies of acutely ill patients with data on the safety of the natural colloid albumin and the artificial colloids HES, dextran, and gelatin. Randomized controlled trials (RCTs), nonrandomized controlled trials (NCTs), cohort studies, pharmacovigilance studies (PVSs), and meta-analyses (MAs) were eligible for inclusion. Search techniques Clinical studies fulfilling the selection criteria were identified, without language or time period restrictions, by computer searches of the MEDLINE and EMBASE bibliographic databases, the Cochrane Controlled Trials Register, and the Cochrane Medical Editors Trial Amnesty of unpublished trials. Search terms included "colloids", "morbidity", and "mortality". Hand searches were conducted of general medical journals and Index Medicus. We contacted the authors of published clinical studies related to colloids and the medical directors of colloid suppliers and examined the reference citations from completed reviews and protocols in the Cochrane Database of Systematic Reviews, other MAs, review articles, and controlled and uncontrolled studies involving colloids. Data extraction and synthesis Two unblinded investigators (M.M.W. and R.J.N.) independently selected studies for inclusion and extracted data about study design, numbers of patients enrolled and/or infusions administered, clinical setting, fluid regimen, and major study findings, as well as study limitations and confounding factors. Differences in interpretation were resolved through discussion. Statistical analysis Study results were generally assessed qualitatively. However, quantitative MAs were performed of data for 2 end points: anaphylactoid reactions and HES-associated pruritus. The meta-analytic methodology was generalized mixed modeling with study-level random effects. Such models are intended to accommodate expected between-study heterogeneity. The incidence rate ratio of anaphylactoid reactions with individual colloids, as compared with albumin as reference standard, was calculated together with the corresponding confidence interval (CI) by means of random-effects Poisson regression. Pruritus associated with HES was modeled by means of random-effects logistic regression. Results were expressed as the odds ratio for occurrence of HES-associated pruritus. For both incidence rate ratio and odds ratio, the absence of the number 1 from the CI signifies a statistically significant effect. Results Included studies Of 189 candidate studies initially identified, 113 studies published from 1944 through 2002 were included.1-3031-6061-9091-113 One RCT was excluded because of fluid overload in the albumin group.114 Numbers of study patients, which were reported in 107 of the included studies, totaled 1.54 × 106 patients. The median number of patients per study was 60, with an interquartile range of 29 to 200. In the remaining 6 studies, the numbers of infusions were reported, and these totaled 1.09 × 108 infusions. The median number of infusions per study was 8.5 × 105 (interquartile range, 1.20-74.0 × 105). Safety data about albumin, HES, dextran, and gelatin were available from 60, 75, 17, and 25 included studies, respectively. Twenty-one of the included studies involved acute illness generally (Table 1), 35 cardiac surgery (Table 2), 19 noncardiac surgery (Table 3), 5 ascites, 4 sepsis, 13 brain injury, 3 dialysis, 6 plasma exchange, and 7 acute hearing loss. (Tables summarizing studies of ascites, sepsis, brain injury, dialysis, plasma exchange, and acute hearing loss are available from the authors.) Of the cardiac surgery studies, 14 were evaluations of extracorporeal circuit pump priming; 19, volume expansion; and 2, both. The most frequently represented study design was the RCT, which accounted for 54 studies. Twenty-eight studies were NCTs, 22 were cohort studies, 6 were PVSs, and 3 were MAs. All adverse events In large-scale PVSs, the reported incidence for adverse events of any severity in albumin recipients was 6.1 to 6.8 per 105 infusions of 5% albumin and 3.1 to 8.6 per 105 infusions of 20% to 25% albumin.7,28 For serious adverse events, an incidence of 1.29 per 106 infusions was reported.111 The PVSs are generally based on spontaneous adverse event reporting and are subject to underreporting. One of these PVSs also included data for gelatin, and the reported incidence of adverse events was similar to that for albumin.7 In a cohort study of 379 patients, the incidence of all HES-associated adverse effects was 4.5%.42 Mortality One MA of RCTs indicated poorer survival in critically ill patients receiving albumin vs crystalloid or no albumin.85 However, authors of a subsequent MA110 considered RCT evidence approximately 3-fold more extensive than that of the first MA, and there was no evidence of increased albumin-associated mortality. Results of higher quality trials suggested a potential survival benefit of albumin.110 Thus, in a multivariate analysis of blinded larger RCTs, mortality was significantly reduced by albumin (odds ratio, 0.78; 95% CI, 0.76-0.81). A large-scale PVS provided evidence that deaths after albumin administration are rare (5.24 per 108 infusions).111 Hemodilution with HES was investigated in 1 RCT of patients with acute ischemic stroke.32 The trial was stopped prematurely because of a significant increase in mortality related to cerebral edema among HES recipients. Anaphylactoid reactions In 9 studies, data were reported on anaphylactoid reactions after 3.63 × 106 total colloid infusions.2,5,6,8,16,26,57,75,84 The pooled incidence of anaphylactoid reactions after albumin administration was 9.44 per 105 infusions (95% CI, 5.04-17.7 per 105 infusions). Infusions of all 3 artificial colloids, as compared with albumin, were associated with significantly increased anaphylactoid reactions (Table 4). Pruritus In 1 study, there was evidence of dextran-associated pruritus in some patients.45 Otherwise, however, reports of this adverse effect were restricted to HES exclusively. Pruritus associated with HES was reported in 14 studies involving a total of 2598 patients, of whom 2173 (83.6%) received HES and 425 (16.4%) did not.45,52,53,55,58,59,76,84,86,95,96,99,105,106 The odds of pruritus were significantly increased by HES exposure (Table 5). The effect of HES on pruritus occurrence depended on dose. Neither HES molecular weight nor HES molar substitution exerted a statistically significant effect on pruritus. In 1 study of patients receiving intensive care, 44% of the patients developing pruritus experienced a severe, persistent, and refractory form of the condition.95 Pruritus associated with HES was typically delayed in onset and manifested as pruritic crises,52,99,105 prompting patients to seek medical attention and seriously detracting from their quality of life.95 Pruritus associated with HES is generally unresponsive to currently available forms of therapy.52 Coagulopathy Results of numerous studies indicate that HES administration can lead to reduction in circulating factor VIII and von Willebrand factor levels, impairment of platelet function, prolongation of partial thromboplastin time and activated partial thromboplastin time, and increase in bleeding complications.27,29,34,40,61,62,69,78,80,82,94,103,104 Coagulopathy and hemorrhage associated with HES are often encountered in cardiac surgery, a setting in which susceptibility to such complications is heightened by transient acquired platelet dysfunction resulting from the procedure. Thus, in cardiac surgery studies with albumin as the control, HES has resulted in platelet depletion and dysfunction, prothrombin time and activated partial thromboplastin time prolongation, and increased postoperative bleeding.3,11,13,15,17,46,48,50,65,92 One NCT of 444 patients revealed significant increases in blood product use, as well as postoperative blood loss, in patients receiving HES for volume expansion.98 The effects of HES on clinical bleeding in cardiac surgery patients depend on dose; however, excessive postoperative bleeding has been reported with HES doses less than the recommended maximum.87 Results of 1 RCT suggested that postoperative bleeding might be greater in patients receiving HES of high rather than medium molecular weight.50 This result was not supported, however, by results of 1 NCT of 200 patients showing postoperative blood loss significantly greater after pump priming with HES of medium molecular weight than with albumin.92 Furthermore, in 1 MA of RCTs, bleeding was increased by HES, as compared with albumin, and the effects of HES of high and medium molecular weight were similar.109 Dextran, as compared with albumin, has been shown to reduce platelets and increase postoperative bleeding in cardiac surgery patients.56 Postoperative blood loss was linearly correlated with the volume of gelatin used to prime the extracorporeal circuit.60 Renal failure All 3 artificial colloids have been associated with renal impairment, and HES has been demonstrated to increase sensitive markers of renal tubule damage in surgical patients.74,93 In 1 RCT of sepsis patients, HES exposure was recently shown to be an independent risk factor for acute renal failure.108 In the renal transplantation setting, HES reduced urinary output, increased creatinine levels and dopamine requirement, and increased the need for hemodialysis or hemodiafiltration.64,66 By contrast, in 1 NCT, no significant difference was evident in delayed graft function after renal transplantation with administration of HES to the donor.89 In a cohort study of patients with acute ischemic stroke, 4.7% experienced acute renal failure associated with dextran infusion.72 Gelatin, as compared with albumin as pump prime in cardiac surgery, elevated creatinine levels.41 Circulatory dysfunction The occurrence of circulatory dysfunction marked by increased plasma renin activity and aldosterone has been investigated in patients who have ascites and are undergoing large-volume paracentesis. The incidence of circulatory dysfunction was significantly higher after infusion of dextran than of albumin in 2 RCTs38,67 but not in a third.47 Circulatory dysfunction was also more frequent in patients receiving gelatin than in those receiving albumin.67 Hepatic dysfunction Repeated infusion of HES in conjunction with dialysis resulted in the development of ascites that necessitated Denver shunt implantation in 1 case.18 In 1 recent study, HES deposition in hepatic Kupffer cells was associated with worsening of hepatic dysfunction after HES infusion.101 Pump priming with HES, as compared with albumin, during cardiac surgery has been found to increase levels of liver enzymes during and after cardiopulmonary bypass surgery.15 Tissue deposition Hydroxyethyl starch is deposited in a variety of tissues, including skin, liver, muscle, spleen, intestine, trophoblast, and placental stroma.18,40,55,96,101 Such deposition often has been described in association with pruritus.55,96 Tissue deposits persist as long as 54 months after HES administration.96 Organ deposition of dextran has been reported in 1 NCT of patients undergoing long-term hemodialysis.35 Tissue deposition of administered albumin has not been detected at necroscopic examination.5 Comment The major conclusion emerging from this systematic review is that there are clinically important differences in safety among colloids. Many of the differences have been demonstrated between albumin and HES, possibly because these 2 colloids have been more extensively investigated than have dextran and gelatin. The incidence of adverse events in albumin recipients was low. Albumin administration was not consistently associated with any characteristic types of adverse events. This observation is perhaps unsurprising, because albumin infusion serves to replenish the normal endogenous colloid. Although albumin is isolated from human plasma, we could identify no evidence of viral disease transmission attributable to albumin. Bleeding associated with artificial colloid administration has been widely reported.3,21,27,40,49,50,56,60,62,73,87,92,98,104,109 Such complications have been particularly frequent in the cardiac surgery setting, necessitating increased blood product use and increased costs of care.87,98 Bleeding complications can be particularly troublesome because of the long half-life of HES and because discontinuation of HES infusion cannot immediately resolve coagulopathy. Although potentially life threatening, anaphylactoid reactions were relatively infrequent for all colloids. Hydroxyethyl starch, as compared with albumin, more than quadrupled the incidence of anaphylactoid reactions, whereas dextran more than doubled them. The incidence of these reactions in recipients of gelatin was greater by more than an order of magnitude than that after albumin infusion. Because artificial colloids are derived from nonhuman source materials, they may be recognized as foreign and hence are more likely to provoke an immune-mediated response. The foreign nature of artificial colloids may also hinder metabolic clearance and promote tissue deposition. Although HES has been widely used for several decades, HES-related pruritus has been widely described only since the early 1990s.45 Its late recognition as a clinical entity appears to be at least partly because of the lengthy delay in onset of symptoms, in many cases occurring after discharge. This adverse effect was initially characterized in otologic patients receiving relatively high HES doses to improve microcirculation. Besides otologic indications, we identified evidence of HES-associated pruritus in studies of general96 and cardiac99 surgery, patients receiving intensive care,95,106 and subarachnoid hemorrhage.105 In our MA, the pooled odds of pruritus were significantly increased by HES exposure. Although the effect was dose related, many patients receiving less than the recommended 20 mL/kg HES maximum were affected.95,99 In a cardiac surgery study, more than half of the patients developing pruritus had received less than the recommended HES maximum.99 We compiled substantial evidence linking HES exposure to increased risk of renal failure. This effect has been characterized in the settings of surgery,74,93 sepsis,108 and kidney transplantation.64,66 Adverse effects of HES in kidney transplantation have, however, been controversial.89 Outside the United States, HES products of varying molecular weight and/or molar substitution have been introduced. It has often been argued that adverse effects of HES are primarily attributable to preparations of higher molecular weight and greater molar substitution.61,70 The basis for such putative differences is the more rapid clearance of HES of lower molecular weight and less highly substituted forms. In our MA, neither HES molecular weight nor molar substitution significantly affected the odds of pruritus. More broadly, our systematic review failed to reveal consistent differences among HES preparations with respect to safety. On the basis of extensive evidence, albumin appears to be in general the safest colloid of the 4 we reviewed. In some settings, other factors such as the desirability of anticoagulant activity might militate in favor of artificial colloids. In any case, results of our review suggest the need to consider the contrasting safety profiles of colloids in clinical decision making. Corresponding author and reprints: Mahlon M. Wilkes, PhD, Hygeia Associates, 17988 Brewer Rd, Grass Valley, CA 95949, (e-mail: mwilkes@hygeiaassociates.com). Accepted for publication August 13, 2003. References 1. 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Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996;1111002- 1010PubMedGoogle ScholarCrossref 68. Schneider MValentine SClarke GMNewman MAPeacock J Acute renal failure in cardiac surgical patients, potentiated by gentamicin and calcium. Anaesth Intensive Care. 1996;24647- 650PubMedGoogle Scholar 69. Treib JHaass APindur G et al. Influence of low and medium molecular weight hydroxyethyl starch on platelets during a long-term hemodilution in patients with cerebrovascular diseases. Arzneimittelforschung. 1996;461064- 1066PubMedGoogle Scholar 70. Treib JHaass APindur GTreib WWenzel ESchimrigk K Influence of intravascular molecular weight of hydroxyethyl starch on platelets. Eur J Haematol. 1996;56168- 172PubMedGoogle ScholarCrossref 71. Wahba ASendtner EBirnbaum DE Fluid resuscitation with Haemaccel vs human albumin following coronary artery bypass grafting. Thorac Cardiovasc Surg. 1996;44178- 182PubMedGoogle ScholarCrossref 72. Biesenbach GKaiser WZazgornik J Incidence of acute oligoanuric renal failure in dextran 40 treated patients with acute ischemic stroke stage III or IV. Ren Fail. 1997;1969- 75PubMedGoogle ScholarCrossref 73. Cope JTBanks DMauney MC et al. Intraoperative hetastarch infusion impairs hemostasis after cardiac operations. Ann Thorac Surg. 1997;6378- 82PubMedGoogle ScholarCrossref 74. Dehne MGMühling JSablotzki APapke GKuntzsch UHempelmann G Einfluß von Hydroxyethylstärke-Lösung auf die Nierenfunktion bei operativen Intensivpatienten. Anasthesiol Intensivmed Notfallmed Schmerzther. 1997;32348- 354PubMedGoogle ScholarCrossref 75. Hedin HLjungström KG Prevention of dextran anaphylaxis: ten years experience with hapten dextran. Int Arch Allergy Immunol. 1997;113358- 359PubMedGoogle ScholarCrossref 76. Metze DReimann SSzepfalusi ZBohle BKraft DLuger TA Persistent pruritus after hydroxyethyl starch infusion therapy: a result of long-term storage in cutaneous nerves. Br J Dermatol. 1997;136553- 559PubMedGoogle ScholarCrossref 77. Owen HGBrecher ME Partial colloid starch replacement for therapeutic plasma exchange. J Clin Apheresis. 1997;1287- 92PubMedGoogle ScholarCrossref 78. Rock GSutton DMFreedman JNair RC Pentastarch instead of albumin as replacement fluid for therapeutic plasma exchange: the Canadian Apheresis Group. J Clin Apheresis. 1997;12165- 169PubMedGoogle ScholarCrossref 79. Saxena NChauhan SRamesh GS A comparison of hetastarch, albumin and Ringer lactate for volume replacement in coronary artery bypass surgery. J Anaesth Clin Pharm. 1997;13117- 120Google Scholar 80. Stoll MTreib JSchenk JF et al. No coagulation disorders under high-dose volume therapy with low-molecular-weight hydroxyethyl starch. Haemostasis. 1997;27251- 258PubMedGoogle Scholar 81. Tigchelaar IGallandat Huet RCKorsten JBoonstra PWvan Oeveren W Hemostatic effects of three colloid plasma substitutes for priming solution in cardiopulmonary bypass. Eur J Cardiothorac Surg. 1997;11626- 632PubMedGoogle ScholarCrossref 82. Treib JHaass APindur G et al. Increased haemorrhagic risk after repeated infusion of highly substituted medium molecular weight hydroxyethyl starch. Arzneimittelforschung. 1997;4718- 22PubMedGoogle Scholar 83. Altman CBernard BRoulot DVitte RLInk O Randomized comparative multicenter study of hydroxyethyl starch versus albumin as a plasma expander in cirrhotic patients with tense ascites treated with paracentesis. Eur J Gastroenterol Hepatol. 1998;105- 10PubMedGoogle ScholarCrossref 84. Bothner UGeorgieff MVogt NH Assessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study. Anesth Analg. 1998;86850- 855PubMedGoogle Scholar 85. Cochrane Injuries Group Albumin Reviewers, Human albumin administration in critically ill patients: systematic review of randomised controlled trials. BMJ. 1998;317235- 240PubMedGoogle ScholarCrossref 86. Gröchenig EAlbegger KDieterich HJ et al. Hydroxyethylstarch-related pruritus: a prospective multicentre investigation of 544 patients. Perfusion. 1998;1162- 69Google Scholar 87. Herwaldt LASwartzendruber SKEdmond MB et al. The epidemiology of hemorrhage related to cardiothoracic operations. Infect Control Hosp Epidemiol. 1998;199- 16PubMedGoogle ScholarCrossref 88. Tigchelaar IGallandat Huet RCBoonstra PWvan Oeveren W Comparison of three plasma expanders used as priming fluids in cardiopulmonary bypass patients. Perfusion. 1998;13297- 303PubMedGoogle ScholarCrossref 89. Deman APeeters PSennesael J Hydroxyethyl starch does not impair immediate renal function in kidney transplant recipients: a retrospective, multicentre analysis. Nephrol Dial Transplant. 1999;141517- 1520PubMedGoogle ScholarCrossref 90. Goss GAWeinstein R Pentastarch as partial replacement fluid for therapeutic plasma exchange: effect on plasma proteins, adverse events during treatment, and serum ionized calcium. J Clin Apheresis. 1999;14114- 121PubMedGoogle ScholarCrossref 91. Karoutsos SNathan NLahrimi AGrouille DFeiss PCox DJ Thrombelastogram reveals hypercoagulability after administration of gelatin solution. Br J Anaesth. 1999;82175- 177PubMedGoogle ScholarCrossref 92. Keyser EJLatter DAMorin JEMurshid AADenis Fde Varennes B Pentastarch versus albumin in cardiopulmonary bypass prime: impact on blood loss. J Card Surg. 1999;14279- 286PubMedGoogle ScholarCrossref 93. Kumle BBoldt JPiper SSchmidt CSuttner SSalopek S The influence of different intravascular volume replacement regimens on renal function in the elderly. Anesth Analg. 1999;891124- 1130PubMedGoogle ScholarCrossref 94. Omar MNShouk TAKhaleq MA Activity of blood coagulation and fibrinolysis during and after hydroxyethyl starch (HES) colloidal volume replacement. Clin Biochem. 1999;32269- 274PubMedGoogle ScholarCrossref 95. Sharland CHuggett ANielson MSFriedmann PS Persistent pruritis after pentastarch infusions in intensive care patients. Anaesthesia. 1999;54500- 501PubMedGoogle ScholarCrossref 96. Sirtl CLaubenthal HZumtobel VKraft DJurecka W Tissue deposits of hydroxyethyl starch (HES): dose-dependent and time-related. Br J Anaesth. 1999;82510- 515PubMedGoogle ScholarCrossref 97. Canver CCNichols RD Use of intraoperative hetastarch priming during coronary bypass. Chest. 2000;1181616- 1620PubMedGoogle ScholarCrossref 98. Knutson JEDeering JAHall FW et al. Does intraoperative hetastarch administration increase blood loss and transfusion requirements after cardiac surgery? Anesth Analg. 2000;90801- 807PubMedGoogle ScholarCrossref 99. Morgan PWBerridge JC Giving long-persistent starch as volume replacement can cause pruritus after cardiac surgery. Br J Anaesth. 2000;85696- 699PubMedGoogle ScholarCrossref 100. Torchia MGDanzinger RG Perioperative blood transfusion and albumin administration are independent risk factors for the development of postoperative infections after colorectal surgery. Can J Surg. 2000;43212- 216PubMedGoogle Scholar 101. Christidis CMal FRamos J et al. Worsening of hepatic dysfunction as a consequence of repeated hydroxyethylstarch infusions. J Hepatol. 2001;35726- 732PubMedGoogle ScholarCrossref 102. Howard GDownward GBowie D Human serum albumin induced hypotension in the postoperative phase of cardiac surgery. Anaesth Intensive Care. 2001;29591- 594PubMedGoogle Scholar 103. Huraux CAnkri AAEyraud D et al. Hemostatic changes in patients receiving hydroxyethyl starch: the influence of ABO blood group. Anesth Analg. 2001;921396- 1401PubMedGoogle ScholarCrossref 104. Jonville-Béra APAutret-Leca EGruel Y Acquired type I von Willebrand's disease associated with highly substituted hydroxyethyl starch. N Engl J Med. 2001;345622- 623PubMedGoogle ScholarCrossref 105. Kimme PJannsen BLedin TGupta AVegfors M High incidence of pruritus after large doses of hydroxyethyl starch (HES) infusions. Acta Anaesthesiol Scand. 2001;45686- 689PubMedGoogle ScholarCrossref 106. Murphy MCarmichael AJLawler PGWhite MCox NH The incidence of hydroxyethyl starch-associated pruritus. Br J Dermatol. 2001;144973- 976PubMedGoogle ScholarCrossref 107. Petroni KCGreen RBirmingham S Hextend is a safe alternative to 5% human albumin for patients undergoing elective cardiac surgery [abstract]. Anesthesiology. 2001;95A198Google Scholar 108. Schortgen FLacherade JCBruneel F et al. Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study. Lancet. 2001;357911- 916PubMedGoogle ScholarCrossref 109. Wilkes MMNavickis RJSibbald WJ Albumin versus hydroxyethyl starch in cardiopulmonary bypass surgery: a meta-analysis of postoperative bleeding. Ann Thorac Surg. 2001;72527- 534PubMedGoogle ScholarCrossref 110. Wilkes MMNavickis RJ Patient survival after human albumin administration: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2001;135149- 164PubMedGoogle ScholarCrossref 111. von Hoegen IWaller C Safety of human albumin based on spontaneously reported serious adverse events. Crit Care Med. 2001;29994- 996PubMedGoogle ScholarCrossref 112. Kuo STHsu WCYoung YH Dextran-induced pulmonary edema in patients with sudden deafness. Otol Neurotol. 2002;23661- 664PubMedGoogle ScholarCrossref 113. Trull AHughes VCooper D et al. Influence of albumin supplementation on tacrolimus and cyclosporine therapy early after liver transplantation. Liver Transpl. 2002;8224- 232PubMedGoogle ScholarCrossref 114. Lucas CEWeaver DHiggins RFLedgerwood AMJohnson SDBouwman DL Effects of albumin versus non-albumin resuscitation on plasma volume and renal excretory function. J Trauma. 1978;18564- 570PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

A Systematic Review of the Comparative Safety of Colloids

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References (134)

Publisher
American Medical Association
Copyright
Copyright © 2004 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.139.5.552
Publisher site
See Article on Publisher Site

Abstract

Abstract Hypothesis Safety differences exist among colloids widely used for fluid management in acutely ill patients, as judged according to the comparative incidence of adverse events. Data Sources Colloid safety data for human subjects were sought, without language or time period restrictions, by means of computer searches of bibliographic and clinical trial databases, hand searches of medical journals and Index Medicus, inquiries with investigators and colloid suppliers, and examination of reference lists. Search terms included "colloids", "morbidity", and "mortality". Study Selection Controlled trials, cohort studies, pharmacovigilance studies, and prior meta-analyses were independently selected by 2 unblinded investigators. Of 189 candidate studies, 113 were included, with safety data encompassing 1.54 × 106 patients and 1.09 × 108 colloid infusions. Data Extraction Two unblinded investigators independently extracted data. Study limitations and confounding factors were tabulated. Data Synthesis With albumin as the reference colloid, the incidence rate ratio for anaphylactoid reactions was 4.51 (95% confidence interval, 2.06-9.89) after hydroxyethyl starch administration, 2.32 (95% confidence interval, 1.21-4.45) after dextran, and 12.4 (95% confidence interval, 6.40-24.0) after gelatin. Pruritus occurrence was significantly increased by hydroxyethyl starch exposure (odds ratio, 1.78; 95% confidence interval, 1.23-2.58). Artificial colloid administration was consistently associated with coagulopathy and clinical bleeding, most frequently in cardiac surgery patients receiving hydroxyethyl starch. On the basis of large-scale pharmacovigilance study results, albumin infusion resulted in a low rate of both total adverse events (3.1 to 8.6 per 105 infusions) and serious adverse events (1.29 per 106 infusions). Conclusions Significant safety differences exist among colloids. Therefore, conclusions regarding the clinical usefulness of colloids as a fluid class should be formed with caution. Colloids promote retention of fluid in the intravascular space, with concomitant reduction of the potential for edema that might compromise the function of organs such as the lungs, myocardium, and gastrointestinal tract.1 The chief colloids currently in routine clinical use worldwide are albumin, hydroxyethyl starch (HES), dextran, and gelatin. Clinically available albumin is a 69-kDa protein purified from human plasma. Hydroxyethyl starch is synthesized by partial hydrolysis of amylopectin plant starch and hydroxyethylation at the C2, C3, and C6 positions of the constituent glucose molecules. Dextran is composed of naturally occurring glucose polymers synthesized by Leuconostoc mesenteroides bacteria growing in sucrose-containing media. Gelatin for clinical use is derived from hydrolysis of bovine collagen followed by being either succinylated or linked to urea. All 3 artificial colloids are polydisperse molecules in a range of sizes. Hydroxyethyl starch is clinically available in an array of forms differing on the basis both of average molecular weight and extent of molar substitution, although in the United States only the HES of high molecular weight (450 kDa) of 0.7 molar substitution ratio has been used in routine fluid management. In the United States, dextran is less extensively used for fluid management than is HES, and gelatin is unavailable for clinical use. Clinically available colloids have generally exhibited similar effectiveness in maintaining colloid oncotic pressure. Thus, colloids have often been viewed as a class of essentially interchangeable inert fluids, and selection of colloid has commonly been based on cost and convenience. Nevertheless, differences in safety profiles among colloids are well recognized.2,3 Such differences underlie, for example, the recommended 1500 mL (20 mL per kilogram of body weight) dose limitation for HES.4 The clinical importance of differences in colloid safety has been debated. Firm conclusions have been difficult to draw, in part because comparative colloid safety has not been systematically reviewed. We here present the results of such a review. Methods Inclusion criteria We systematically sought all studies of acutely ill patients with data on the safety of the natural colloid albumin and the artificial colloids HES, dextran, and gelatin. Randomized controlled trials (RCTs), nonrandomized controlled trials (NCTs), cohort studies, pharmacovigilance studies (PVSs), and meta-analyses (MAs) were eligible for inclusion. Search techniques Clinical studies fulfilling the selection criteria were identified, without language or time period restrictions, by computer searches of the MEDLINE and EMBASE bibliographic databases, the Cochrane Controlled Trials Register, and the Cochrane Medical Editors Trial Amnesty of unpublished trials. Search terms included "colloids", "morbidity", and "mortality". Hand searches were conducted of general medical journals and Index Medicus. We contacted the authors of published clinical studies related to colloids and the medical directors of colloid suppliers and examined the reference citations from completed reviews and protocols in the Cochrane Database of Systematic Reviews, other MAs, review articles, and controlled and uncontrolled studies involving colloids. Data extraction and synthesis Two unblinded investigators (M.M.W. and R.J.N.) independently selected studies for inclusion and extracted data about study design, numbers of patients enrolled and/or infusions administered, clinical setting, fluid regimen, and major study findings, as well as study limitations and confounding factors. Differences in interpretation were resolved through discussion. Statistical analysis Study results were generally assessed qualitatively. However, quantitative MAs were performed of data for 2 end points: anaphylactoid reactions and HES-associated pruritus. The meta-analytic methodology was generalized mixed modeling with study-level random effects. Such models are intended to accommodate expected between-study heterogeneity. The incidence rate ratio of anaphylactoid reactions with individual colloids, as compared with albumin as reference standard, was calculated together with the corresponding confidence interval (CI) by means of random-effects Poisson regression. Pruritus associated with HES was modeled by means of random-effects logistic regression. Results were expressed as the odds ratio for occurrence of HES-associated pruritus. For both incidence rate ratio and odds ratio, the absence of the number 1 from the CI signifies a statistically significant effect. Results Included studies Of 189 candidate studies initially identified, 113 studies published from 1944 through 2002 were included.1-3031-6061-9091-113 One RCT was excluded because of fluid overload in the albumin group.114 Numbers of study patients, which were reported in 107 of the included studies, totaled 1.54 × 106 patients. The median number of patients per study was 60, with an interquartile range of 29 to 200. In the remaining 6 studies, the numbers of infusions were reported, and these totaled 1.09 × 108 infusions. The median number of infusions per study was 8.5 × 105 (interquartile range, 1.20-74.0 × 105). Safety data about albumin, HES, dextran, and gelatin were available from 60, 75, 17, and 25 included studies, respectively. Twenty-one of the included studies involved acute illness generally (Table 1), 35 cardiac surgery (Table 2), 19 noncardiac surgery (Table 3), 5 ascites, 4 sepsis, 13 brain injury, 3 dialysis, 6 plasma exchange, and 7 acute hearing loss. (Tables summarizing studies of ascites, sepsis, brain injury, dialysis, plasma exchange, and acute hearing loss are available from the authors.) Of the cardiac surgery studies, 14 were evaluations of extracorporeal circuit pump priming; 19, volume expansion; and 2, both. The most frequently represented study design was the RCT, which accounted for 54 studies. Twenty-eight studies were NCTs, 22 were cohort studies, 6 were PVSs, and 3 were MAs. All adverse events In large-scale PVSs, the reported incidence for adverse events of any severity in albumin recipients was 6.1 to 6.8 per 105 infusions of 5% albumin and 3.1 to 8.6 per 105 infusions of 20% to 25% albumin.7,28 For serious adverse events, an incidence of 1.29 per 106 infusions was reported.111 The PVSs are generally based on spontaneous adverse event reporting and are subject to underreporting. One of these PVSs also included data for gelatin, and the reported incidence of adverse events was similar to that for albumin.7 In a cohort study of 379 patients, the incidence of all HES-associated adverse effects was 4.5%.42 Mortality One MA of RCTs indicated poorer survival in critically ill patients receiving albumin vs crystalloid or no albumin.85 However, authors of a subsequent MA110 considered RCT evidence approximately 3-fold more extensive than that of the first MA, and there was no evidence of increased albumin-associated mortality. Results of higher quality trials suggested a potential survival benefit of albumin.110 Thus, in a multivariate analysis of blinded larger RCTs, mortality was significantly reduced by albumin (odds ratio, 0.78; 95% CI, 0.76-0.81). A large-scale PVS provided evidence that deaths after albumin administration are rare (5.24 per 108 infusions).111 Hemodilution with HES was investigated in 1 RCT of patients with acute ischemic stroke.32 The trial was stopped prematurely because of a significant increase in mortality related to cerebral edema among HES recipients. Anaphylactoid reactions In 9 studies, data were reported on anaphylactoid reactions after 3.63 × 106 total colloid infusions.2,5,6,8,16,26,57,75,84 The pooled incidence of anaphylactoid reactions after albumin administration was 9.44 per 105 infusions (95% CI, 5.04-17.7 per 105 infusions). Infusions of all 3 artificial colloids, as compared with albumin, were associated with significantly increased anaphylactoid reactions (Table 4). Pruritus In 1 study, there was evidence of dextran-associated pruritus in some patients.45 Otherwise, however, reports of this adverse effect were restricted to HES exclusively. Pruritus associated with HES was reported in 14 studies involving a total of 2598 patients, of whom 2173 (83.6%) received HES and 425 (16.4%) did not.45,52,53,55,58,59,76,84,86,95,96,99,105,106 The odds of pruritus were significantly increased by HES exposure (Table 5). The effect of HES on pruritus occurrence depended on dose. Neither HES molecular weight nor HES molar substitution exerted a statistically significant effect on pruritus. In 1 study of patients receiving intensive care, 44% of the patients developing pruritus experienced a severe, persistent, and refractory form of the condition.95 Pruritus associated with HES was typically delayed in onset and manifested as pruritic crises,52,99,105 prompting patients to seek medical attention and seriously detracting from their quality of life.95 Pruritus associated with HES is generally unresponsive to currently available forms of therapy.52 Coagulopathy Results of numerous studies indicate that HES administration can lead to reduction in circulating factor VIII and von Willebrand factor levels, impairment of platelet function, prolongation of partial thromboplastin time and activated partial thromboplastin time, and increase in bleeding complications.27,29,34,40,61,62,69,78,80,82,94,103,104 Coagulopathy and hemorrhage associated with HES are often encountered in cardiac surgery, a setting in which susceptibility to such complications is heightened by transient acquired platelet dysfunction resulting from the procedure. Thus, in cardiac surgery studies with albumin as the control, HES has resulted in platelet depletion and dysfunction, prothrombin time and activated partial thromboplastin time prolongation, and increased postoperative bleeding.3,11,13,15,17,46,48,50,65,92 One NCT of 444 patients revealed significant increases in blood product use, as well as postoperative blood loss, in patients receiving HES for volume expansion.98 The effects of HES on clinical bleeding in cardiac surgery patients depend on dose; however, excessive postoperative bleeding has been reported with HES doses less than the recommended maximum.87 Results of 1 RCT suggested that postoperative bleeding might be greater in patients receiving HES of high rather than medium molecular weight.50 This result was not supported, however, by results of 1 NCT of 200 patients showing postoperative blood loss significantly greater after pump priming with HES of medium molecular weight than with albumin.92 Furthermore, in 1 MA of RCTs, bleeding was increased by HES, as compared with albumin, and the effects of HES of high and medium molecular weight were similar.109 Dextran, as compared with albumin, has been shown to reduce platelets and increase postoperative bleeding in cardiac surgery patients.56 Postoperative blood loss was linearly correlated with the volume of gelatin used to prime the extracorporeal circuit.60 Renal failure All 3 artificial colloids have been associated with renal impairment, and HES has been demonstrated to increase sensitive markers of renal tubule damage in surgical patients.74,93 In 1 RCT of sepsis patients, HES exposure was recently shown to be an independent risk factor for acute renal failure.108 In the renal transplantation setting, HES reduced urinary output, increased creatinine levels and dopamine requirement, and increased the need for hemodialysis or hemodiafiltration.64,66 By contrast, in 1 NCT, no significant difference was evident in delayed graft function after renal transplantation with administration of HES to the donor.89 In a cohort study of patients with acute ischemic stroke, 4.7% experienced acute renal failure associated with dextran infusion.72 Gelatin, as compared with albumin as pump prime in cardiac surgery, elevated creatinine levels.41 Circulatory dysfunction The occurrence of circulatory dysfunction marked by increased plasma renin activity and aldosterone has been investigated in patients who have ascites and are undergoing large-volume paracentesis. The incidence of circulatory dysfunction was significantly higher after infusion of dextran than of albumin in 2 RCTs38,67 but not in a third.47 Circulatory dysfunction was also more frequent in patients receiving gelatin than in those receiving albumin.67 Hepatic dysfunction Repeated infusion of HES in conjunction with dialysis resulted in the development of ascites that necessitated Denver shunt implantation in 1 case.18 In 1 recent study, HES deposition in hepatic Kupffer cells was associated with worsening of hepatic dysfunction after HES infusion.101 Pump priming with HES, as compared with albumin, during cardiac surgery has been found to increase levels of liver enzymes during and after cardiopulmonary bypass surgery.15 Tissue deposition Hydroxyethyl starch is deposited in a variety of tissues, including skin, liver, muscle, spleen, intestine, trophoblast, and placental stroma.18,40,55,96,101 Such deposition often has been described in association with pruritus.55,96 Tissue deposits persist as long as 54 months after HES administration.96 Organ deposition of dextran has been reported in 1 NCT of patients undergoing long-term hemodialysis.35 Tissue deposition of administered albumin has not been detected at necroscopic examination.5 Comment The major conclusion emerging from this systematic review is that there are clinically important differences in safety among colloids. Many of the differences have been demonstrated between albumin and HES, possibly because these 2 colloids have been more extensively investigated than have dextran and gelatin. The incidence of adverse events in albumin recipients was low. Albumin administration was not consistently associated with any characteristic types of adverse events. This observation is perhaps unsurprising, because albumin infusion serves to replenish the normal endogenous colloid. Although albumin is isolated from human plasma, we could identify no evidence of viral disease transmission attributable to albumin. Bleeding associated with artificial colloid administration has been widely reported.3,21,27,40,49,50,56,60,62,73,87,92,98,104,109 Such complications have been particularly frequent in the cardiac surgery setting, necessitating increased blood product use and increased costs of care.87,98 Bleeding complications can be particularly troublesome because of the long half-life of HES and because discontinuation of HES infusion cannot immediately resolve coagulopathy. Although potentially life threatening, anaphylactoid reactions were relatively infrequent for all colloids. Hydroxyethyl starch, as compared with albumin, more than quadrupled the incidence of anaphylactoid reactions, whereas dextran more than doubled them. The incidence of these reactions in recipients of gelatin was greater by more than an order of magnitude than that after albumin infusion. Because artificial colloids are derived from nonhuman source materials, they may be recognized as foreign and hence are more likely to provoke an immune-mediated response. The foreign nature of artificial colloids may also hinder metabolic clearance and promote tissue deposition. Although HES has been widely used for several decades, HES-related pruritus has been widely described only since the early 1990s.45 Its late recognition as a clinical entity appears to be at least partly because of the lengthy delay in onset of symptoms, in many cases occurring after discharge. This adverse effect was initially characterized in otologic patients receiving relatively high HES doses to improve microcirculation. Besides otologic indications, we identified evidence of HES-associated pruritus in studies of general96 and cardiac99 surgery, patients receiving intensive care,95,106 and subarachnoid hemorrhage.105 In our MA, the pooled odds of pruritus were significantly increased by HES exposure. Although the effect was dose related, many patients receiving less than the recommended 20 mL/kg HES maximum were affected.95,99 In a cardiac surgery study, more than half of the patients developing pruritus had received less than the recommended HES maximum.99 We compiled substantial evidence linking HES exposure to increased risk of renal failure. This effect has been characterized in the settings of surgery,74,93 sepsis,108 and kidney transplantation.64,66 Adverse effects of HES in kidney transplantation have, however, been controversial.89 Outside the United States, HES products of varying molecular weight and/or molar substitution have been introduced. It has often been argued that adverse effects of HES are primarily attributable to preparations of higher molecular weight and greater molar substitution.61,70 The basis for such putative differences is the more rapid clearance of HES of lower molecular weight and less highly substituted forms. 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Journal

Archives of SurgeryAmerican Medical Association

Published: May 5, 2004

Keywords: albumins,colloids,infusion procedures,cardiac surgery procedures,adverse event,pruritus,blood coagulation disorders,hetastarch,gelatin,hemorrhage,dextran,fluid management,anaphylactoid reaction

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