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

• ClinicalTrials.gov Identifier: NCT04216784
• Recruitment Status: Recruiting
• First Posted: January 3, 2020
• Last Update Posted: December 15, 2022
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Nalvey, Rush University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cirrhosis, Liver; Volume Overload; Fluid Overload	Drug: Furosemide Injection; Drug: Albumin Human	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Diuretic Effect With Furosemide Alone Versus the Combination of Furosemide and Albumin in Cirrhotic Patients
• Actual Study Start Date: December 19, 2019
• Estimated Primary Completion Date: December 30, 2023
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in weight [ Time Frame: 2-7 days ]
   Change in weight defined as weight loss of 1 kilogram
2. Amount of urine [ Time Frame: 2-7 days ]
   The amount of urine produced over 24 hours.

Secondary Outcome Measures :

1. Change in serum creatinine [ Time Frame: baseline and daily while patient is enrolled in study (2-7 days) ]
   Change in renal function
2. Hospital length of stay [ Time Frame: Through completion of study, up to an average of 1 year ]
   duration of hospital admission
3. 30-day readmission rates [ Time Frame: 30 days from discharge ]
   Number of occurrences that the patient is readmitted after discharge within 30 days
4. Patient survival [ Time Frame: 1 year ]
   Patient survival

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Nicole Alvey; 312-942-2024; nicole_alvey@Rush.edu

Contact: Melissa Chaung; melissa_chaung@rush.edu

Locations

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: Melissa Chaung, PharmD

Contact: Nicole Alvey, PharmD

Sponsors and Collaborators

Rush University Medical Center

More Information

• Responsible Party: Nalvey, Principal investigator, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT04216784
• Other Study ID Numbers: 19092507-IRB01
• First Posted: January 3, 2020
• Last Update Posted: December 15, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Furosemide; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Potassium Chloride Symporter Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action