Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Albumin Assisted Diuresis in Patients with Cirrhosis Decompensated by Ascites and Peripheral Edema, a Proof-of-concept Double Blind Randomized Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06812390

Enrollment

Registered

2025-02-06

Start date

2025-02-28

Completion date

2027-03-31

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites Hepatic, Cirrhosis

Keywords

albumin, cirrhosis, ascites, diuresis

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.

Interventions

DRUGAlbumin infusion (25% albumin)

Albumin 25 gram infusion

DRUGNormal Saline (0.9% NaCl)

100 cc of normal saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Proof of concept, randomized, cross over, double-blind placebo-controlled study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in fractional excretion of sodium (FENa)	6 hours (baseline vs hour 6 after albumin vs placebo administration)	Change in fractional excretion of sodium (FENa) with administration of albumin vs placebo

Secondary

Measure	Time frame	Description
Changes in neuro hormonal markers	6 hours and 24 hours	Changes in neuro hormonal markers including norepinephrine, renin, aldosterone

Countries

United States

Contacts

Primary ContactAnahita Rabiee, MD, MHS

anahita.rabiee@va.gov203-932-5711

Backup ContactLynn F. Buchwalder, M.S.

Lynn.Buchwalder@va.gov203-932-5711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026