Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis Ascites Hepatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

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.

Group Type PLACEBO_COMPARATOR

Albumin infusion (25% albumin)

Intervention Type DRUG

Albumin 25 gram infusion

Normal Saline (0.9% NaCl)

Intervention Type DRUG

100 cc of normal saline

Interventions

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Albumin infusion (25% albumin)

Albumin 25 gram infusion

Intervention Type DRUG

Normal Saline (0.9% NaCl)

100 cc of normal saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No