Low-dose vs. standard-dose albumin in cirrhosis and infection
Trial question
Is low-dose albumin noninferior to standard-dose albumin in patients with cirrhosis and infections?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
17.0% female
83.0% male
N = 174
174 patients (30 female, 144 male).
Inclusion criteria: consecutive patients with cirrhosis with proven infections.
Key exclusion criteria: mean arterial pressure < 65 mmHg; congestive HF with an ejection fraction < 50%; HCC; CKD with a serum creatinine > 2 mg/dL; mechanical ventilation at enrollment.
Interventions
N=116 low-dose albumin (20 g/day for 5 days plus standard medical treatment).
N=58 standard-dose albumin (1.5 g/kg and 1 g/kg on days 1 and 3, respectively, plus standard medical treatment).
Primary outcome
In-hospital mortality
9.4%
10.34%
10.3 %
7.8 %
5.2 %
2.6 %
0.0 %
Low-dose
albumin
Standard-dose
albumin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in in-hospital mortality (9.4% vs. 10.34%; RR 0.91, 95% CI -36.02 to 37.84).
Secondary outcomes
No significant difference in mortality at day 30 (19.8% vs. 24.1%; RR 0.82, 95% CI -2.68 to 4.32).
No significant difference in improvement in sensorium (58.8% vs. 63.6%; RR 0.92, 95% CI -3.86 to 5.7).
Conclusion
In consecutive patients with cirrhosis with proven infections, low-dose albumin was noninferior to standard-dose albumin with respect to a in-hospital mortality.
Reference
Jayadeep V Devisetty, Bipadabhanjan Mallick, Dibyaloahan Praharaj et al. A Study of Impact of Fixed-Dose Albumin Infusion on Outcome in Patients With Cirrhosis and Infection: A Randomized Open-label Clinical Trial. J Clin Exp Hepatol. 2024 Jan-Feb;14(1):101270.
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