BACKGROUND It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units (ICUs) affects survival. We conducted a multicenter, randomized, double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU. METHODS We randomly assigned patients who had been admitted to the ICU
to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days. The primary outcome measure was death from any cause during the 28-day period after randomization. RESULTS Of the 6997 patients who underwent randomization, 3497 were assigned to receive albumin and 3500 to receive saline; the two groups had similar baseline characteristics. There were 726 deaths in the albumin group, as compared with 729 deaths in the saline group (relative risk of death, 0. 99; 95 percent confidence interval, 0. 91 to 1. 09; P=0. 87). The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups (P=0. 85). There were no significant differences between the groups in the mean (+/-SD) numbers of days spent in the ICU (6. 5+/-6. 6 in the albumin group and 6. 2+/-6. 2 in the saline group, P=0. 44), days spent in the hospital (15. 3+/-9. 6 and 15. 6+/-9. 6, respectively; P=0. 30), days of mechanical ventilation (4. 5+/-6. 1 and 4. 3+/-5. 7, respectively; P=0. 74), or days of renal-replacement therapy (0. 5+/-2. 3 and 0. 4+/-2. 0, respectively; P=0. 41). CONCLUSIONS In patients in the ICU, use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days.