Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Last updated: March 10, 2025
Sponsor: Anahita Rabiee MD MHS
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disorders

Liver Disease

Scar Tissue

Treatment

Albumin infusion (25% albumin)

Normal Saline (0.9% NaCl)

Clinical Study ID

NCT06812390
1791319
680800001061
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Outpatient patients with decompensated cirrhosis with past or current ascites andpersistent lower extremity edema despite oral diuretic titration

  • Serum albumin of < 3.5 g/dL

  • Age >=18 years old

Exclusion

Exclusion Criteria:

  • Patients with GFR < 30mL/min/1.73 m2

  • Changes in oral diuretic regimen in the past 7 days (**patients can enter the studyafter 7 days of the change)

  • Large Volume paracentesis (LVP) in the past 7 days (**patients can enter the studyafter 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 oreplerenone in place of spironolactone, and Bumex/Torsemide in place of furosemideare 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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Albumin infusion (25% albumin)
Phase: 2
Study Start date:
February 28, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • West Haven VA Medical Center

    West Haven, Connecticut 06516
    United States

    Active - Recruiting

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