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


RESULTS
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).


CONCLUSIONS
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.
Schortgen
F
F
Medical Intensive-care Unit, Henri Mondor Hospital, Assistance Publique-H pitaux de Paris, University Paris 12, Créteil, France.
Lacherade
J C
JC
Bruneel
F
F
Cattaneo
I
I
Hemery
F
F
Lemaire
F
F
Brochard
L
L
D058186:Acute Kidney Injury / Q000139:chemically induced*; D000328:Adult; D000368:Aged; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods; D005602:France / Q000453:epidemiology; D005780:Gelatin / Q000009:adverse effects*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000009:adverse effects*; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010952:Plasma Substitutes / Q000009:adverse effects*; D011446:Prospective Studies; D012306:Risk; D018805:Sepsis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D012772:Shock, Septic / Q000150:complications / Q000401:mortality / Q000628:therapy; D018709:Statistics, Nonparametric; D016019:Survival Analysis
D006895:Hydroxyethyl Starch Derivatives; D010952:Plasma Substitutes; D005780:Gelatin