Background The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported. Methods We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% 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 with renal-replacement therapy. Results A 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 six predefined 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 occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (5.3% vs. 2.8%, P<0.001). Conclusions In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168 .).
AD - From the George Institute for Global Health (J.A.M., S.F., R.B., L.B., A.C., D.G., P.G., B.L., C.B.T., S.A.R.W.), University of New South Wales (J.A.M., B.L.), St. George Hospital (J.A.M.), University of Sydney (J.A.M., S.F., A.C., D.G., C.B.T.), Royal North Shore Hospital (S.F.), and Royal Prince Alfred Hospital (D.G., D.R.), Sydney; University of Melbourne and Austin Hospital, Melbourne, VIC (R.B.), University of Queensland and Royal Brisbane and Women's Hospital, Brisbane, QLD (J.L.), and University of Western Australia and Royal Perth Hospital, Perth, WA (S.A.R.W.) - all in Australia; and Auckland City Hospital, Auckland, New Zealand (C.M., S.M.). AN - 23075127 BT - New England Journal of Medicine DP - NLM ET - 2012/10/19 LA - Eng N1 - Myburgh, John AFinfer, SimonBellomo, RinaldoBillot, LaurentCass, AlanGattas, DavidGlass, ParisaLipman, JeffreyLiu, BetteMcArthur, ColinMcGuinness, ShayRajbhandari, DorrilynTaylor, Colman BWebb, Steven A Rthe CHEST Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials GroupN Engl J Med. 2012 Oct 17. N2 -Background The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported. Methods We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% 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 with renal-replacement therapy. Results A 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 six predefined 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 occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (5.3% vs. 2.8%, P<0.001). Conclusions In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168 .).
PY - 2012 SN - 1533-4406 (Electronic)0028-4793 (Linking) T2 - New England Journal of Medicine TI - Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care ER -