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The Food and Drug Administration (FDA) has issued a notice declaring albumin safe for fluid resuscitation in critically ill patients. In 1998, the FDA had questioned the safety of administering albumin to these patients based on research available at that time. A meta-analysis had suggested that critically ill patients receiving albumin for hypovolemia had a higher risk of death than a similar group of patients who'd received 0.9% sodium chloride solution.


The FDA now considers the issue resolved, based on results from the Saline versus Albumin Fluid Evaluation (SAFE) study. Published in 2004, the SAFE study showed that critically ill patients receiving fluid resuscitation with either 4% albumin or 0.9% sodium chloride solution had similar mortality rates at 28 days. Because this study didn't include patients with burns, however, the FDA can't vouch for the safety of albumin for these patients. More studies are needed to determine albumin's effects on patients with burns, traumatic brain injury, and septic shock.




FDA press release, May 16, 2005; A comparison of albumin and saline for fluid resuscitation in the intensive care unit, The New England Journal of Medicine, The SAFE study investigators, May 27, 2004.