The SAFE Study Investigators. N Engl J Med 2004.
This RCT showed no difference in the primary outcome of 28-day mortality between 4% albumin and normal saline (20.9% vs. 21.1%, RR 0.99; 95% CI 0.91–1.09) or secondary outcomes, including durations of ICU stay, hospitalization, mechanical ventilation, and renal-replacement therapy among 6,933 adult ICU patients in Australia and New Zealand. A subsequent post- showed high mortality at 24 months in 420 patients with traumatic brain injury (33.2% vs. 20.4%; RR, 1.63; 95% CI 1.17– 2.26).
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