Clinical trial NCT04216784: Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cirrhosis, Liver
Volume Overload
Fluid Overload
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: 2-7 days
measure: Amount of Urine
timeFrame: 2-7 days
Secondary outcomes:
measure: Change in Serum Creatinine
timeFrame: baseline and daily while patient is enrolled in study (2-7 days)
measure: Hospital Length of Stay
timeFrame: Through completion of study, up to an average of 1 year
measure: 30-day Readmission Rates
timeFrame: 30 days from discharge
measure: Patient Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Lance Lance Lineberger, PharmD
role: PRINCIPAL_INVESTIGATOR
References: