Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Connecticut
West Haven VA Medical Center
RECRUITING
West Haven
Contact Information
Primary
Anahita Rabiee, MD, MHS
anahita.rabiee@va.gov
203-932-5711
Backup
Lynn F. Buchwalder, M.S.
Lynn.Buchwalder@va.gov
203-932-5711
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-03
Participants
Target number of participants: 20
Treatments
Active_comparator: Albumin first
Albumin for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive placebo for one dose.
Placebo_comparator: Placebo first
Placebo for one dose, followed by at least 14 day washout period, before crossing over to the alternate arm to receive albumin for one dose.
Related Therapeutic Areas
Sponsors
Leads: Anahita Rabiee MD MHS
Collaborators: Grifols Shared Services North America Inc