6/29/23, 11:41 PM SAFE Pathway Feedback Search Clinical Topics Home Studies SAFE 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 N = 6997 60.0% male 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 21.1 % 21.1 20.9 15.8 % 10.6 % 5.3 % No significant difference 0.0 % https://web.pathway.md/studies/recBUYi8MaqnpulAi 1/2 6/29/23, 11:41 PM SAFE Pathway Albumin Saline 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 Finfer S, Bellomo R, Boyce N 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. Open reference URL https://web.pathway.md/studies/recBUYi8MaqnpulAi 2/2