Recruiting
Phase 2

Albumin Assisted Diuresis

Sponsor:

Anahita Rabiee MD MHS

Code:

NCT06812390

Conditions

Cirrhosis

Ascites Hepatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Albumin infusion (25% albumin)

Normal Saline (0.9% NaCl)

Study Details

Brief 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.

Conditions

Cirrhosis

Ascites Hepatic

Study ID

NCT06812390

Start date

Feb 28, 2025

Status verified date

Feb, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Albumin infusion (25% albumin)

Albumin 25 gram infusion

Normal Saline (0.9% NaCl)

100 cc of normal saline

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 and Locations

Central contacts

Anahita Rabiee, MD, MHS

203-932-5711anahita.rabiee@va.gov

Lynn F. Buchwalder, M.S.

203-932-5711Lynn.Buchwalder@va.gov

Locations

West Haven VA Medical Center

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Anahita Rabiee, MD, MHS

203-932-5711anahita.rabiee@va.gov

Lynn F Buchwalder, M.S.

203-932-5711Lynn.Buchwalder@va.gov

More Information

Sponsor

Anahita Rabiee MD MHS

Last update posted

Mar 11, 2025

Last verified

Feb, 2025

Keywords

  • albumin
  • cirrhosis
  • ascites
  • diuresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anahita Rabiee MD MHS on 2025-03-11.