Use of Hydroxyethyl Starch in Sepsis Patients Increases Risk of Renal Replacement Therapy, Transfusion, Serious Adverse Events

Newer hydroxyethyl starch (HES) products with molecular weight of 130kDa and substitution ratios ranging from 0.38 to 0.45 (130/0.38-0.45) have been claimed to be safer than higher molecular weight (200/0.5-0.6) HES products, which were shown to cause acute kidney injury in two randomized trials in patients with sepsis. Danish investigators conducted a systematic review and meta-analysis of randomized trials to assess the effects of 130/0.38-0.45 HES products versus crystalloid of human albumin on mortality, kidney injury, bleeding and serious adverse events on patients with sepsis.

Nine trials that randomized a total of 3,456 patients with sepsis were included. Six trials studied Voluven 6% HES 130/0.4 in saline (Fresenius Kabi), and the other three trials evaluated other or unspecified 130/0.4-0.42 HES products. Two trials compared HES against 20% albumin, while the remaining trials used crystalloid as a comparator. Overall, HES versus crystalloid or albumin did not affect the relative risk of death (1.04, 95 percent confidence interval, 0.89 to 1.22), but in predefined analysis of four trials with low risk of bias, the relative risk of death was 1.11 (1.00 to 1.23, 0.95 to 1.29). Renal replacement therapy was used more in patients receiving HES (1.36, 1.08 to 1.72). More patients in the HES groups were transfused with red blood cells (1.29, 1.13 to 1.48) and had serious adverse events (1.30, 1.02 to 1.67).

The investigators concluded that use of HES 130/0.38-0.45 increased the requirement for renal replacement therapy and transfusion with red blood cells, and resulted in more serious adverse events in patients with sepsis.