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Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients

NCT04216784 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-09-16

Study results available
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Summary

A common complication of the progression of cirrhosis is fluid retention (ascites, edema, or pleural effusion). Loop diuretics are the treatment of choice for fluid retention in cirrhotic patients; however, many of these patients demonstrate diuretic resistance, requiring higher doses of the diuretics to achieve adequate diuresis. The cause of this diuretic resistance is hypothesized to be secondary to hypoalbuminemia which has led some providers to give human albumin in combination with loop diuretics to increase intravascular volume and facilitate diuresis. However, this practice remains controversial because minimal data exists to support its efficacy. The purpose of this study is to compare the efficacy of diuretics alone versus diuretics in combination with albumin in cirrhotic patients presenting with fluid retention.

Conditions

  • Cirrhosis, Liver
  • Volume Overload
  • Fluid Overload

Interventions

DRUG

Furosemide Injection

Patient will receive furosemide intravenously

DRUG

Albumin Human

Patient will receive albumin (25%) 12.5 gm intravenously

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Lance Lance Lineberger, PharmD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2023-12-30
Completion
2024-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04216784 on ClinicalTrials.gov