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SAFE

"Saline versus Albumin Fluid Evaluation (SAFE) in ICU Patients".The New England Journal of Medicine. 2004. 350(22):2247-2256.

Links to original sources: Wiki Journal Post Full Journal Article

Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Funding 10 Further Reading

Clinical Question


In ICU patients requiring intravascular volume resuscitation, does the choice of resuscitation fluid (albumin or saline) affect survival?

Bottom Line


In ICU patients requiring fluid resuscitation, there is no significant difference in 28-day mortality rates between those treated with albumin and those treated with saline.

Major Points


The SAFE study was a multicenter, double-blind, randomized trial that compared the use of 4% albumin versus normal saline for intravascular fluid resuscitation in a diverse group of ICU patients. The trial found no significant difference in 28-day mortality or in secondary outcomes like mechanical ventilation days and length of ICU stay, suggesting that albumin and saline have similar clinical efficacy for fluid resuscitation.

Guidelines


As of the knowledge cutoff date for this article, specific guidelines considering the results of the SAFE study have not been detailed.

Design


Multicenter, double-blind, parallel group, randomized, placebo-controlled trial N=6,997 Albumin group (n=3,497) Saline group (n=3,500)

Population


Inclusion Criteria: ICU patients 18 years or older requiring fluid administration to maintain or increase intravascular volume. Exclusion Criteria: Patients admitted post-cardiac surgery, post-liver transplantation, or for treatment of burns. Baseline Characteristics: Similar baseline characteristics between both groups, including APACHE II scores and organ failure assessment.

Interventions


Patients were randomized to receive either 4% albumin or normal saline for intravascular fluid resuscitation in the 28 days following randomization.

Outcomes


Primary Outcome: Death from any cause within 28 days of randomization. Secondary Outcomes: Duration of mechanical ventilation, duration of renal-replacement therapy, length of ICU and hospital stay, rate of new single-organ, and multiple-organ failure.

Funding


Supported by multiple health boards, departments, councils, and CSL (manufacturers of Albumex).

Further Reading


The full text is available from the The New England Journal of Medicine as linked in the original article.