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

Sponsor
Rush University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04216784
Collaborator
(none)
150
1
2
72.4
2.1

Study Details

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
  • 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
Anticipated 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 :
Dec 19, 2019
Anticipated Primary Completion Date :
Nov 30, 2020
Anticipated Study Completion Date :
Dec 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 [2-7 days]

    Change in weight defined as weight loss of 1 kilogram

  2. Amount of urine [2-7 days]

    The amount of urine produced over 24 hours.

Secondary Outcome Measures

  1. Change in serum creatinine [baseline and daily while patient is enrolled in study (2-7 days)]

    Change in renal function

  2. Hospital length of stay [Through completion of study, up to an average of 1 year]

    duration of hospital admission

  3. 30-day readmission rates [30 days from discharge]

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

  4. Patient survival [1 year]

    Patient survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melissa Chaung, PharmD, Principal investigator, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04216784
Other Study ID Numbers:
  • 19092507-IRB01
First Posted:
Jan 3, 2020
Last Update Posted:
Jan 13, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Jan 13, 2020