Actively Recruiting
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
Led by Anahita Rabiee MD MHS · Updated on 2025-03-11
20
Participants Needed
1
Research Sites
104 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
A small, pilot proof-of-concept placebo-controlled trial to explore the effects of albumin on diuresis in patients with cirrhosis, ascites and lower extremity edema. We will additionally investigate albumin's effect on preventing neurohumoral activation, and acute kidney injury after diuresis.
CONDITIONS
Official 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 less than 3.5 g/dL
- Age 18 years or older
You will not qualify if you...
- Patients with estimated glomerular filtration rate less than 30 mL/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 or higher
- Use of other diuretics such as hydrochlorothiazide (amiloride or eplerenone acceptable replacements for spironolactone, Bumex or Torsemide acceptable replacements for furosemide)
- Hypotension (mean arterial pressure less than 65 mmHg or systolic blood pressure less than 90 mmHg)
- Severe low sodium (less than 125 mEq/L)
- Previous diagnosis of overt heart failure with systolic ejection fraction less than 50%
- Baseline oxygen requirement
- Allergy to albumin preparations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Lynn F. Buchwalder, M.S.
CONTACT
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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