Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Anahita Rabiee MD MHS
Study ID
NCT06812390
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ascites Hepatic
  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Albumin infusion (25% albumin) — DRUG
    Albumin 25 gram infusion
  • Normal Saline (0.9% NaCl) — DRUG
    100 cc of normal saline

Study Details

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.

Key Dates

Start date
Feb 28, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Change in fractional excretion of sodium (FENa) [ Time Frame: 6 hours (baseline vs hour 6 after albumin vs placebo administration) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
West Haven VA Medical CenterWest HavenConnecticut06516
Anahita Rabiee, MD, MHS
[email protected]
203-932-5711
Lynn F Buchwalder, M.S.
[email protected]
203-932-5711

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