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

NCT04216784 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 19092507-IRB01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Serum Creatinine

  Through completion of study, up to an average of 1 year

• Hospital Length of Stay

  Through completion of study, up to an average of 1 year

• 30-day Readmission Rates

  30 days from discharge

• Patient Survival

  1 year

Study Arms (2)

Furosemide (Lasix) alone

ACTIVE COMPARATOR

Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours

Drug: Furosemide Injection

Combination of furosemide (Lasix) and albumin

ACTIVE COMPARATOR

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; Drug: Albumin Human

Interventions

Furosemide Injection DRUG

Patient will receive furosemide intravenously

Combination of furosemide (Lasix) and albumin; Furosemide (Lasix) alone

Albumin Human DRUG

Patient will receive albumin (25%) 12.5 gm intravenously

Combination of furosemide (Lasix) and albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Edema

Interventions

Furosemide; Serum Albumin, Human

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Results Point of Contact

• Title: Lance Lineberger
• Organization: Rush University Medical Center

Lance_Lineberger@rush.edu

312-942-5126

Study Officials

• Lance Lance Lineberger, PharmD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 3, 2020
• Study Start: December 19, 2019
• Primary Completion: December 30, 2023
• Study Completion: April 1, 2024
• Last Updated: September 16, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)