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

Primary Purpose

Cirrhosis, Liver, Volume Overload, Fluid Overload

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Furosemide Injection

Albumin Human

About this trial

This is an interventional treatment trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Furosemide (Lasix) alone

Combination of furosemide (Lasix) and albumin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in weight

Change in weight defined as weight loss of 1 kilogram

Amount of urine

The amount of urine produced over 24 hours.

Secondary Outcome Measures

Change in serum creatinine

Change in renal function

Hospital length of stay

duration of hospital admission

30-day readmission rates

Number of occurrences that the patient is readmitted after discharge within 30 days

Patient survival

Full Information

NCT ID

NCT04216784

First Posted

December 23, 2019

Last Updated

December 13, 2022

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04216784

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 19, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Liver, Volume Overload, Fluid Overload

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Furosemide (Lasix) alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Combination of furosemide (Lasix) and albumin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Furosemide Injection

Intervention Description

Patient will receive furosemide intravenously

Intervention Type

Drug

Intervention Name(s)

Albumin Human

Intervention Description

Patient will receive albumin (25%) 12.5 gm intravenously

Primary Outcome Measure Information:

Title

Change in weight

Description

Change in weight defined as weight loss of 1 kilogram

Time Frame

2-7 days

Title

Amount of urine

Description

The amount of urine produced over 24 hours.

Time Frame

2-7 days

Secondary Outcome Measure Information:

Title

Change in serum creatinine

Description

Change in renal function

Time Frame

baseline and daily while patient is enrolled in study (2-7 days)

Title

Hospital length of stay

Description

duration of hospital admission

Time Frame

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

Title

30-day readmission rates

Description

Number of occurrences that the patient is readmitted after discharge within 30 days

Time Frame

30 days from discharge

Title

Patient survival

Description

Patient survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicole Alvey

Phone

312-942-2024

nicole_alvey@Rush.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Chaung

melissa_chaung@rush.edu

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Chaung, PharmD

First Name & Middle Initial & Last Name & Degree

Nicole Alvey, PharmD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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