Pilot Study of Albumin Infusion to Improve Diuresis in Adults with Cirrhosis, Ascites, and Leg Swelling

What this Trial Is About

Researchers are evaluating the effects of albumin on diuresis in patients with cirrhosis, ascites, and persistent lower extremity edema. This pilot, proof-of-concept, placebo-controlled trial aims to explore how albumin influences sodium excretion, neurohumoral activation, and the risk of acute kidney injury after diuresis in this population. The study is a double-blind, randomized Phase 2 trial sponsored by Anahita Rabiee MD MHS. Participants will receive one dose of either albumin 25 grams infused as 25% albumin or placebo 100 cc of normal saline, followed by at least a 14-day washout period. After the washout, participants will cross over to receive the alternate treatment. This crossover design allows each participant to receive both albumin and placebo during the study. During the study, researchers will measure changes in the fractional excretion of sodium at 6 hours after treatment and monitor neurohormonal markers at 6 and 24 hours. The study involves outpatient participants who will be monitored closely for kidney function, blood pressure, sodium levels, and other safety parameters. Participation will last through both treatment periods plus washout, ensuring thorough assessment of albumins effects compared to placebo.

Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites