Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study

Background Hydroxyethylstarch used for volume restoration in brain-dead kid ney donors has been associated with impaired kidney function in the transpl ant recipients. We undertook a multicentre randomised study to assess the f requency of acute renal failure (ARF) in patients with severe sepsis or sep tic shock treated with hydroxyethylstarch or gelatin. Methods Adults with severe sepsis or septic shock were enrolled prospective ly in three intensive-care units in France. They were randomly assigned 6% hydroxyethylstarch (200 kDa, 0.60-0.66 substitution) or 3% fluid-modified g elatin. The primary endpoint was ARF (a two-fold increase in serum creatini ne from baseline or need for renal replacement therapy). Analyses were by i ntention to treat. Findings 129 patients were enrolled over 18 months. Severity of illness and serum creatinine (median 143 [IQR 88-203] vs 114 [91-175] mu mol/L) were s imilar at baseline in the hydroxyethylstarch and gelatin groups. The freque ncies of ARF (27/65 [42%] vs 15/64 [23%], p=0.028) and oliguria (35/62 [56% ] vs 23/63 [37%], p=0.025) and the peak serum creatinine concentration (225 [130-339] vs 169 [106-273] mu mol/L, p=0.04) were significantly higher in the hydroxyethylstarch group than in the gelatin group. in a multivariate a nalysis, risk factors for acute renal failure included mechanical ventilati on (odds ratio 4.02 [95% CI 1.37-11.8], p=0.013) and use of hydroxyethylsta rch (2.57 [1.13-5.83], p=0.026). Interpretations The use of this preparation of hydroxyethylstarch as a plas ma-volume expander is an independent risk factor for ARF in patients with s evere sepsis or septic shock.