TY - JOUR
T1 - Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care
AU - Myburgh, J.A.
AU - Finfer, S.
AU - Bellomo, R.
AU - Billot, L.
AU - Cass, A.
AU - Gattas, D.
AU - Glass, P.
AU - Lipman, J.
AU - Liu, B.
AU - Mcarthur, C.
AU - Mcguinness, S.
AU - Rajbhandari, D.
AU - Taylor, C.B.
AU - Webb, Steve
PY - 2012/10/17
Y1 - 2012/10/17
N2 - Background The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have notbeen fully evaluated, and adverse effects of HES on survival and renal function havebeen reported.Methods We randomly assigned 7000 patients who had been admitted to an intensive careunit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kDand a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death,or 90 days after randomization. The primary outcome was death within 90 days.Secondary outcomes included acute kidney injury and failure and treatment withrenal-replacement therapy.ResultsA total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%)in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval[CI], 0.96 to 1.18; P = 0.26). There was no significant difference in mortality in sixpredefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients(7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk,1.21; 95% CI, 1.00 to 1.45; P = 0.04). In the HES and saline groups, renal injury occurredin 34.6% and 38.0% of patients, respectively (P = 0.005), and renal failureoccurred in 10.4% and 9.2% of patients, respectively (P = 0.12). HES was associatedwith significantly more adverse events (5.3% vs. 2.8%, P
AB - Background The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have notbeen fully evaluated, and adverse effects of HES on survival and renal function havebeen reported.Methods We randomly assigned 7000 patients who had been admitted to an intensive careunit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kDand a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death,or 90 days after randomization. The primary outcome was death within 90 days.Secondary outcomes included acute kidney injury and failure and treatment withrenal-replacement therapy.ResultsA total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%)in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval[CI], 0.96 to 1.18; P = 0.26). There was no significant difference in mortality in sixpredefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients(7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk,1.21; 95% CI, 1.00 to 1.45; P = 0.04). In the HES and saline groups, renal injury occurredin 34.6% and 38.0% of patients, respectively (P = 0.005), and renal failureoccurred in 10.4% and 9.2% of patients, respectively (P = 0.12). HES was associatedwith significantly more adverse events (5.3% vs. 2.8%, P
U2 - 10.1056/NEJMoa1209759
DO - 10.1056/NEJMoa1209759
M3 - Article
SN - 0028-4793
VL - 367
SP - 1901
EP - 1911
JO - New England Journal of Medicine
JF - New England Journal of Medicine
ER -