SAFE
Trial question
What is the effect of fluid resuscitation with saline in a heterogeneous population of patients in the ICU?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 6997
6997 patients (2800 female, 4197 male)
Inclusion criteria: patients who had been admitted to the ICU
Key exclusion criteria: ICU admittance after cardiac surgery, after liver transplantation, or for the treatment of burns
Interventions
N=3497 albumin (4% for a period of 28 days)
N=3500 saline (0.9% for a period of 28 days)
Primary outcome
Rate of death from any cause during the 28-day period
20.9
21.1
21.1 %
15.8 %
10.6 %
5.3 %
0.0 %
Albumin
Saline
No significant
difference ↔
No significant difference in the rate of death from any cause during the 28-day period (20.9% vs. 21.1%; RR 0.99, 99% CI 0.91 to 1.09)
Secondary outcomes
No significant difference in length of stay in the ICU (6.5 days vs. 6.2 days; AD 0.24 days, 95% CI -0.06 to 0.54)
No significant difference in duration of mechanical ventilation (4.5 days vs. 4.3 days; AD 0.19 days, 95% CI -0.08 to 0.47)
Borderline significant increase in duration of RRT (0.48 days vs. 0.39 days; AD 0.09 days, 95% CI 0 to 0.19)
Safety outcomes
No significant difference in new single-organ or multiple-organ failure.
Conclusion
In patients who had been admitted to the ICU, albumin was not superior to saline with respect to the rate of death from any cause during the 28-day period.
Reference
Simon Finfer, Rinaldo Bellomo, Neil Boyce et al. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004 May 27;350(22):2247-56.
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