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

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

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.

Study Overview

• Status: Terminated
• Conditions: Fluid Overload; Cirrhosis, Liver; Volume Overload
• Intervention / Treatment: Drug: Furosemide Injection; Drug: Albumin Human

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Furosemide (Lasix) alone; Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours	Drug: Furosemide Injection; Patient will receive furosemide intravenously
Active Comparator: Combination of furosemide (Lasix) and albumin; Cohort 2 will receive combination of furosemide (Lasix) 40 to 80 mg IVP BID and albumin (25%) 12.5 grams IV BID for at least 48 hours	Drug: Furosemide Injection; Patient will receive furosemide intravenously; Drug: Albumin Human; Patient will receive albumin (25%) 12.5 gm intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Change in weight defined as weight loss of 1 kilogram	2-7 days
Amount of Urine	The amount of urine produced over 24 hours.	2-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Creatinine	Changes in renal function were observed in patients from the two study arms . Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.	Through completion of study, up to an average of 1 year
Hospital Length of Stay	duration of hospital admission Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.	Through completion of study, up to an average of 1 year
30-day Readmission Rates	Number of occurrences that the patient is readmitted after discharge within 30 days Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.	30 days from discharge
Patient Survival	Patient survival rates to be closely monitored in patients from the two study arms Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.	1 year

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Lance Lance Lineberger, PharmD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Liver Diseases; Chemically-Induced Disorders; Water-Electrolyte Imbalance; Poisoning; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Liver Cirrhosis; Water Intoxication; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Amides; Aniline Compounds; Amines; Blood Proteins; Sulfonamides; Sulfanilamides; Sulfones; Albumins; Serum Albumin; Furosemide; Serum Albumin, Human
• Other Study ID Numbers: 19092507-IRB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes