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
Pietro Caironi, Gianni Tognoni, Serge Masson 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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