What is albumin studying for cirrhosis with ascites?

This trial is studying how albumin affects fluid removal and kidney function in patients with cirrhosis and ascites. Researchers want to see if albumin helps prevent kidney injury and reduces harmful hormonal changes during diuresis. The study is led by Dr. Anahita Rabiee and aims to better understand albumin's role in managing this condition.

Who may be eligible for this cirrhosis clinical trial?

Adults aged 18 or older with decompensated cirrhosis, current or past ascites, and persistent leg swelling despite diuretics may be eligible. Participants must have a serum albumin level below 3.5 g/dL and be able to safely undergo the treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this cirrhosis clinical trial?

Study-related care, including the albumin or placebo infusion and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for potential travel costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06812390

Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial

Led by Anahita Rabiee MD MHS · Updated on 2025-03-11

Participants Needed

Research Sites

12 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Outpatient patients with decompensated cirrhosis with past or current ascites and persistent lower extremity edema despite oral diuretic titration
Serum albumin of < 3.5 g/dL
Age >=18 years old

You will not qualify if you...

Patients with GFR < 30mL/min/1.73 m2
Changes in oral diuretic regimen in the past 7 days (patients can enter after 7 days)
Large volume paracentesis in the past 7 days (patients can enter after 7 days)
Albumin infusion within the previous 14 days (patients can enter after 14 days)
Spontaneous bacterial peritonitis in the past month
Active variceal bleeding
Current hepatic encephalopathy (>= Grade 2 based on West Haven criteria)
Co-administration of other diuretics such as hydrochlorothiazide (amiloride or eplerenone may be used instead of spironolactone; Bumex or Torsemide may be used instead of furosemide)
Hypotension (Mean arterial pressure <65 mmHg, systolic blood pressure <90 mmHg)
Severe hyponatremia (Sodium <125 mEq/L)
Previous diagnosis of overt heart failure (systolic EF < 50%)
Baseline oxygen requirement
Hypersensitivity to albumin preparations

Research Team

Anahita Rabiee, MD, MHS

Lynn F. Buchwalder, M.S.

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