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

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.