SAFE Trial

NEJM

March 27, 2004

A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit.

What was the research question?

  • Does fluid resuscitation with 4% albumin, compared to normal saline, affect mortality for patients in the ICU?


How did they do it?

  • A randomized, double blinded, controlled trial in 16 ICUs in Australia.

  • 6997 ICU patients were randomized to receive 4% albumin (3497 patients) or 0.9% sodium chloride (3500 patients) for intravascular-fluid resuscitation.

  • Stratified by center and according to whether there was a diagnosis of trauma.

  • The primary outcome measure was 28-day mortality after randomization.


What did they find?

  • 28-day mortality was not significantly different between the albumin group and the saline group (20.9% vs. 21.1%, P=0.87).

  • There was a trend towards a better 28-day mortality in patients with severe sepsis (30.7% vs 35.3%, P=0.09), and a trend towards worse 28-day mortality in patients with trauma (13.6% vs. 10%, P=0.06).

  • Rate of a new single-organ or multiple-organ failure was similar in the two groups (P=0.85).

  • No significant difference in secondary outcomes that included numbers of days spent in the ICU (P=0.44), days spent in the hospital (P=0.30), days of mechanical ventilation (P=0.74), or days of renal-replacement therapy (P=0.41).

  • Post hoc analysis of trauma subgroup demonstrated a higher mortality with albumin in patients with traumatic brain injury (24.5% vs. 15.1%, P=0.009, NNH 11).


Are there any limitations?

  • · Sub-group analyses had insufficient power.


What does it mean?

  • There is no difference in 28-day outcome in ICU patients whether 4% albumin or 0.9% sodium chloride was used for fluid resuscitation.

  • Avoid using albumin in traumatic head injuries.

SAFE Trial