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No Mortality Benefit with Albumin Administration in Severe Sepsis (ALBIOS)


Clinical question

Does albumin administration reduce mortality in critically ill patients with sepsis?

Bottom line

The use of albumin along with crystalloid solutions in patients with severe sepsis does not affect mortality. (LOE = 1b-)


Caironi P, Tognoni G, Masson S, et al, for the ALBIOS Study Investigators. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med 2014;370(15):1412-1421.

Study design

Randomized controlled trial (nonblinded)

Funding source





Inpatient (ICU only)


Using concealed allocation, these investigators randomized adult patients in the intensive care unit (ICU) with severe sepsis within the previous 24 hours to receive either 300 mL of 20% albumin plus crystalloid solution or crystalloid solution alone. The treatment group received albumin daily from randomization through day 28 or until discharge from the ICU. Crystalloid solution was administered as clinically indicated in both groups. Baseline characteristics of the 2 groups were similar and analysis was by intention to treat. There were no significant differences detected in either 28-day or 90-day mortality between the groups, although a lower-than-expected mortality rate in the control group may have underpowered the study. Secondary outcomes were also similar, including number of new organ failures, hospital and ICU lengths of stay, and need for renal replacement therapy. The albumin group had a shorter time to suspension of vasopressor/inotropic agents (3 vs 4 days; P = .007), indicating a decreased use of these agents. Finally, a post-hoc subgroup analysis of those patients with confirmed septic shock suggested decreased mortality at 90 days in the albumin group. However, this type of analysis, since it is not prespecified, is very susceptible to bias.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

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