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

Abstract

BACKGROUND:

Hydroxyethylstarch used for volume restoration in brain-dead kidney donors has been associated with impaired kidney function in the transplant recipients. We undertook a multicentre randomised study to assess the frequency of acute renal failure (ARF) in patients with severe sepsis or septic shock treated with hydroxyethylstarch or gelatin.

METHODS:

Adults with severe sepsis or septic shock were enrolled prospectively in three intensive-care units in France. They were randomly assigned 6% hydroxyethylstarch (200 kDa, 0.60-0.66 substitution) or 3% fluid-modified gelatin. The primary endpoint was ARF (a two-fold increase in serum creatinine from baseline or need for renal replacement therapy). Analyses were by intention 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] micromol/L) were similar at baseline in the hydroxyethylstarch and gelatin groups. The frequencies 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] micromol/L, p=0.04) were significantly higher in the hydroxyethylstarch group than in the gelatin group. In a multivariate analysis, risk factors for acute renal failure included mechanical ventilation (odds ratio 4.02 [95% CI 1.37-11.8], p=0.013) and use of hydroxyethylstarch (2.57 [1.13-5.83], p=0.026).

INTERPRETATIONS:

The use of this preparation of hydroxyethylstarch as a plasma-volume expander is an independent risk factor for ARF in patients with severe sepsis or septic shock.

• Authors: F Schortgen, J C Lacherade, F Bruneel, I Cattaneo, F Hemery, F Lemaire, L Brochard
• Journal: Lancet (London, England) (Lancet) Vol. 357 Issue 9260 Pg. 911-6 (Mar 24 2001) ISSN: 0140-6736 [Print] England
• PMID: 11289347 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hydroxyethyl Starch Derivatives
• Plasma Substitutes
• Gelatin

Topics

• Acute Kidney Injury (chemically induced)
• Adult
• Aged
• Female
• Fluid Therapy (adverse effects, methods)
• France (epidemiology)
• Gelatin (adverse effects)
• Humans
• Hydroxyethyl Starch Derivatives (adverse effects)
• Intensive Care Units
• Male
• Middle Aged
• Multivariate Analysis
• Plasma Substitutes (adverse effects)
• Prospective Studies
• Risk
• Sepsis (complications, mortality, therapy)
• Shock, Septic (complications, mortality, therapy)
• Statistics, Nonparametric
• Survival Analysis