Mortality after hydroxyethyl starch 130/0.4 infusion: An updated meta-analysis of randomized trials

Abstract

BACKGROUND: Hydroxyethyl starch (HES) is in widespread clinical use for volume therapy with colloids. According to the most recent meta-analysis performed in 2010, published studies are of poor quality and report too few events to reliably estimate the benefits or risks of administering 6% HES 130/0.4. As results from new trials, reporting on a large number of events became available in 2011 and 2012, an updated meta-analysis was performed. METHODS: Randomised controlled trials comparing the effects of 6% HES 130/0.4 with other colloid or crystalloid solutions were analysed for pooled effect size on mortality in eligible studies published up to 20 February 2012. RESULTS: Overall, 13 studies reporting 1,131 participants met the inclusion criteria. The weight of evidence contributed by the two new trials was 51.3%. The pooled relative risk (RR) for mortality increased to 1.14 with a 95% confidence interval (CI) of 0.89 to 1.46. Publication bias favoring HES 130/0.4 was present (p = 0.038). Adjustment for the observed publication bias increased the RR for mortality to 1.25 (CI, 0.98 to 1.58; p = 0.069). No heterogeneity was found (I2, 0%; CI, 0% to 32%; p = 0.81). CONCLUSIONS: Large-scale trials should help more precisely to determine the effect of HES 130/0.4 on mortality. In the interim, best current evidence suggests a trend toward higher mortality among HES 130/0.4 recipients.