Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    150
  • sponsor
    Rush University Medical Center
Updated on 24 February 2022
edema
ascites
furosemide
diuretics
loop diuretic
cirrhosis
albumin human
fluid retention
furosemide injection

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.

Description

The purpose of this single center, prospective study is to compare the efficacy of two strategies for diuresis in patients with cirrhosis, the use of furosemide (Lasix) alone versus the combination of furosemide (Lasix ) and albumin (25%). The investigators will perform a single-center, prospective study with data collected as result of standard of care at Rush University Medical Center (RUMC). Patients who are 18 years of age and older, have diagnosed cirrhosis, and present to RUMC with fluid retention will be identified by the Hepatology and/or Surgery attending and be screened for inclusion in the study. Each patient will be randomized into one of the two cohorts and will have 50% chance of being placed into either cohort. Cohort 1 will receive furosemide (Lasix) 40 to 80 mg intravenous push (IVP) twice a day (BID) for at least 48 hours and cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams BID for at least 48 hours.

Details
Condition Cirrhosis, Liver, Volume Overload, Fluid Overload
Treatment Furosemide Injection, Albumin Human
Clinical Study IdentifierNCT04216784
SponsorRush University Medical Center
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (age >18 years old)
Diagnosis of cirrhosis
Presents with fluid retention as defined as ascites, edema, or pulmonary effusions requiring diuresis

Exclusion Criteria

Patients who are younger than 18 years of age
Patients who are currently pregnant
Patients who present with a serum creatinine greater than 2 mg/dL
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