SAFE
Saline versus Albumin Fluid Evaluation
Patient / Population Intervention / Exposure Comparison Outcome
In 6,997 ICU patients requiring fluid resuscitation, 4% albumin did not change 28-day mortality versus 0.9% saline, with harm in the traumatic brain injury subgroup.
N
6,997
Design
Multicentre RCT, ANZ
Endpoint
28-day all-cause mortality
Relevance
1
Result20.9% vs 21.1% (RR 0.99, 95% CI 0.91-1.09; p=0.87). Trauma/TBI subgroup 28-day mortality 24.5% (albumin) vs 15.1% (saline), RR 1.62 (95% CI 1.12-2.34), p=0.009.
SAFE Study Investigators. N Engl J Med. 2004;350(22):2247-2256. 10.1056/NEJMoa040232
Discussion & critique
Settled the colloid-vs-crystalloid debate for routine ICU care; avoid albumin in TBI.