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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04216784
• Other study ID #: 19092507-IRB01
• Status: Terminated
• Phase: Phase 4
• Start date: December 19, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fluid Overload
• Liver Cirrhosis
• Volume Overload

Intervention

Drug:
• Furosemide Injection
Patient will receive furosemide intravenously
• Albumin Human
Patient will receive albumin (25%) 12.5 gm intravenously

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Change in weight defined as weight loss of 1 kilogram	2-7 days
Primary	Amount of urine	The amount of urine produced over 24 hours.	2-7 days
Secondary	Change in serum creatinine	Change in renal function	baseline and daily while patient is enrolled in study (2-7 days)
Secondary	Hospital length of stay	duration of hospital admission	Through completion of study, up to an average of 1 year
Secondary	30-day readmission rates	Number of occurrences that the patient is readmitted after discharge within 30 days	30 days from discharge
Secondary	Patient survival	Patient survival	1 year