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

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ClinicalTrials.gov Identifier: NCT04216784
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Melissa Chaung, PharmD, Rush University Medical Center

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.

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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 : November 30, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216784


Contacts
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Contact: Melissa Chaung melissa_chaung@rush.edu
Contact: Nicole Alvey nicole_alvey@rush.edu

Locations
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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
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Responsible Party: Melissa Chaung, PharmD, Principal investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04216784    
Other Study ID Numbers: 19092507-IRB01
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Liver Cirrhosis
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