Clinical Outcomes of Intravenous Albumin Administration After Acute Variceal Hemorrhage in Patients with Cirrhosis: An Open-Label, Randomized Controlled Trial.

BACKGROUND

There are limited data on the safety and efficacy of intravenous albumin after variceal hemorrhage (VH) in cirrhosis.

METHODS

Patients with cirrhosis (Child-Pugh classes B and C) with hypoalbuminemia (< 3.5 g/dL) and VH were randomized to receive either standard medical therapy (SMT) or SMT with intravenous albumin (2 g/kg, SMT + A) for 3 days after hemostasis. Hepatic venous pressure gradient (HVPG) was measured on days 1 and 3. Primary outcome was a composite of new-onset acute kidney injury (AKI), spontaneous bacterial peritonitis (SBP), hepatic encephalopathy (HE) and all-cause mortality at 6 weeks. Secondary outcomes included 5- and 42-day rebleeding rate and the need for rescue therapy.

RESULTS

From December 2022 to October 2024, 136 patients were randomized, of whom 123 (SMT: 63, SMT + A: 60) patients received the allocated interventions. The median Child-Pugh and MELD score was 9 (8-10) and 14.8 (11.7-19.7), respectively. Alcohol was the leading etiology of cirrhosis. Patients receiving SMT + A had similar composite rates of HE, SBP, AKI, and all-cause mortality at 6 weeks (8 [13.3%, 95% CI 5.9 to 24.6%]) as compared to SMT alone (11 [17.5%, 95% CI 9.1 to 29.1%]; p = 0.53). There were no differences in the rates of 5-day rebleeding or mortality between the two groups. The median change in HVPG at day 3 compared to day 1 (SMT alone: 0 [- 2 to + 1.5] versus SMT + A: 0 [- 2 to + 2]; p = 0.41) was similar between both groups.

CONCLUSION

Intravenous albumin use is safe after an episode of VH in cirrhosis, but does not reduce 6-week mortality or prevent new-onset SBP/organ failures (CTRI/2022/10/046898).