Fluid replacement with hydroxyethyl starch in critical care--a reassessment.

BACKGROUND Hydroxyethyl starch (HES) is used for fluid replacement in millions of patients around the world every year, yet it has been found to have adverse effects that have a negative impact on patient survival. Recent clinical trials with a modern HES solution (HES 130) and meta-analyses now enable a reassessment of its risks and benefits. METHODS On the basis of a selective literature search focusing on reports of the use of HES 130/0.4 and HES 130/0.42 in sepsis, trauma, and intensive care medicine, data from randomized controlled trials (RCTs) are presented, and up-to-date meta-analyses and reviews are discussed. Moreover, the authors conducted an independent meta-analysis of HES 130 in comparison to crystalloids or albumin in intensive care medicine, sepsis, and trauma. RESULTS Seven RCTs were evaluated, involving a total of 7838 patients treated for sepsis or trauma, or in intensive care. HES 130 was associated with a higher cumulative risk of death (relative risk [RR] 1.10, 95% confidence interval [CI] 1.01-1.20), more frequent need for a renal replacement procedure (RR 1.26, 95% CI 1.08-1.46), and more frequent need for blood transfusion (RR 1.22, 95% CI 1.08-1.37). There was no patient-relevant benefit. Four recent meta-analyses of data from a total of more than 10 000 patients confirmed these concerns about the safety of HES in general and, in particular, of low-molecular-weight HES 130 for patients in intensive care. The safety of 6% HES 130 in the immediate perioperative period has not been adequately demonstrated. DISCUSSION Because of safety concerns, fluid replacement with HES in critically ill patients cannot be recommended. Evidence for its superior efficacy, safety and cost effectiveness in preoperative use is also lacking.