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.