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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04216784
Other study ID # 19092507-IRB01
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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