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Original Article
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Volume 350:2247-2256 May 27, 2004 Number 22
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A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit
The SAFE Study Investigators

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ABSTRACT

Background It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units (ICUs) affects survival. We conducted a multicenter, randomized, double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU.

Methods We randomly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days. The primary outcome measure was death from any cause during the 28-day period after randomization.

Results Of the 6997 patients who underwent randomization, 3497 were assigned to receive albumin and 3500 to receive saline; the two groups had similar baseline characteristics. There were 726 deaths in the albumin group, as compared with 729 deaths in the saline group (relative risk of death, 0.99; 95 percent confidence interval, 0.91 to 1.09; P=0.87). The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups (P=0.85). There were no significant differences between the groups in the mean (±SD) numbers of days spent in the ICU (6.5±6.6 in the albumin group and 6.2±6.2 in the saline group, P=0.44), days spent in the hospital (15.3±9.6 and 15.6±9.6, respectively; P=0.30), days of mechanical ventilation (4.5±6.1 and 4.3±5.7, respectively; P=0.74), or days of renal-replacement therapy (0.5±2.3 and 0.4±2.0, respectively; P=0.41).

Conclusions In patients in the ICU, use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days.


Source Information

The Saline versus Albumin Fluid Evaluation (SAFE) Study is a collaboration of the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Australian Red Cross Blood Service, and the George Institute for International Health. The writing committee (Simon Finfer, M.B., B.S., Rinaldo Bellomo, M.B., B.S., M.D., Neil Boyce, M.B., B.S., Ph.D., Julie French, R.N., John Myburgh, M.B., B.Ch., Ph.D., and Robyn Norton, Ph.D., M.P.H.) takes responsibility for the content of this article.

Address reprint requests to Dr. Finfer at ANZICS CTG, Level 3, 10 Ievers St., Carlton, VIC 3053, Australia, or at ctg{at}anzics.com.au.

Full Text of this Article


Related Letters:

Fluid Resuscitation in the Intensive Care Unit
Haynes G. R., Berman K. E., Neff T. A., Stocker R., Spahn D. R., Barone J. E., Primack W. A., Estes K., Walter E. C., Wendorf R., Kim Y., Finfer S., Boyce N., Norton R., Cook D.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:1905-1908, Oct 28, 2004. Correspondence

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