ALBIOS
Trial question
What is the role of albumin replacement in patients with severe sepsis or septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.4% female
60.6% male
N = 1818
1818 patients (717 female, 1093 male)
Inclusion criteria: patients with severe sepsis
Key exclusion criteria: age < 18 years, terminal state, known adverse reaction to albumin administration, severe sepsis or septic shock in patients after proved or suspected head injury, congestive HF (NYHA class of 3 or 4), hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephrotic syndrome, burns
Interventions
N=903 albumin (20% albumin and crystalloid solution for fluid replacement)
N=907 crystalloids (crystalloid solution alone for fluid replacement)
Primary outcome
Death at 28 days
31.8
32
32.0 %
24.0 %
16.0 %
8.0 %
0.0 %
Albumin
Crystalloids
No significant difference ↔
No significant difference in death at 28 days (31.8% vs. 32%; RR 1, 95% CI 0.87 to 1.14)
Secondary outcomes
No significant difference in death from any cause at 90 days (41.1% vs. 43.6%; RR 0.94, 95% CI 0.85 to 1.05)
Conclusion
In patients with severe sepsis, albumin was not superior to crystalloids with respect to death at 28 days.
Reference
Caironi P, Tognoni G, Masson S et al. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med. 2014 Apr 10;370(15):1412-21.
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