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Michael E. Barron, MD; Mahlon M. Wilkes, PhD; Roberta J. Navickis, PhD

Arch Surg. 2004;139:552-563.

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 x 10⁶ patients and 1.09 x 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.

From the Department of Anesthesiology, University of Miami School of Medicine, Miami, Fla (Dr Barron); and Hygeia Associates, Grass Valley, Calif (Drs Wilkes and Navickas). Dr Barron is a consultant/lecturer for the American Red Cross.

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