ATTIRE
Trial question
What is the role of albumin infusions to increase the albumin level to a target of ≥ 30 g/L in patients hospitalized with decompensated cirrhosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 777
777 patients (227 female, 550 male).
Inclusion criteria: patients hospitalized with decompensated cirrhosis who had a serum albumin level < 30 g/L.
Key exclusion criteria: advanced HCC associated with a life expectancy < 8 weeks; receipt of palliative care.
Interventions
N=380 albumin (targeted 20% human albumin solution for up to 14 days or until discharge).
N=397 standard care (standard medical care).
Primary outcome
Rate of infection from any cause, kidney dysfunction, or death between days 3 and 15 after initiation of treatment
29.7%
30.2%
30.2 %
22.6 %
15.1 %
7.5 %
0.0 %
Albumin
Standard
care
No significant
difference ↔
No significant difference in the rate of infection from any cause, kidney dysfunction, or death between days 3 and 15 after initiation of treatment (29.7% vs. 30.2%; OR 0.98, 95% CI 0.71 to 1.33).
Secondary outcomes
No significant difference in death at day 28 (14% vs. 15.6%; OR 0.86, 95% CI 0.57 to 1.3).
No significant difference in new infection (20.8% vs. 17.9%; OR 1.22, 95% CI 0.85 to 1.75).
No significant difference in kidney dysfunction (10.5% vs. 14.4%; OR 0.68, 95% CI 0.44 to 1.11).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients hospitalized with decompensated cirrhosis who had a serum albumin level < 30 g/L, albumin was not superior to standard care with respect to the rate of infection from any cause, kidney dysfunction, or death between days 3 and 15 after initiation of treatment.
Reference
Louise China, Nick Freemantle, Ewan Forrest et al. A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis. N Engl J Med. 2021 Mar 4;384(9):808-817.
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