Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
RecruitingPhase 2
Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with GFR \< 30mL/min/1.73 m2 * Changes in oral diuretic regimen in the past 7 days (\*\*patients can enter the study after 7 days of the change) * Large Volume paracentesis (LVP) in the past 7 days (\*\*patients can enter the study after 7 days) * Albumin infusion within the previous 14 days (\*\* patients can enter the study 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 in place of spironolactone, and Bumex/Torsemide in place of furosemide are acceptable) * 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
About the study
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.
What is being tested
- Albumin infusion (25% albumin) (drug)
- Normal Saline (0.9% NaCl) (drug)
Sponsor: Anahita Rabiee MD MHS · Participants: 20 · Started: Feb 28, 2025
Contact the study team
- Anahita Rabiee, MD, MHS · Phone: 203-932-5711
- Lynn F. Buchwalder, M.S. · Phone: 203-932-5711
Official record on ClinicalTrials.gov — NCT06812390
Locations in the U.S.
| Connecticut | West Haven VA Medical Center, West Haven |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.