Actively Recruiting
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
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
A
Anahita Rabiee MD MHS
Lead Sponsor
G
Grifols Shared Services North America, Inc.
Collaborating Sponsor
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 albumin's effects compared to placebo.
CONDITIONS
Brief Title
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
Who Can Participate
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 4 weeks including washout periods
Participants receive one dose of either albumin infusion or placebo, followed by at least a 14-day washout period before crossing over to receive the alternate treatment dose.
2 treatment visits with at least 14 days between doses
Trial Site Locations
Total: 1 location
1
West Haven VA Medical Center
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
A
Anahita Rabiee, MD, MHS
L
Lynn F. Buchwalder, M.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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