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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cirrhosis, Liver, Volume Overload, Fluid Overload

Intervention / Treatment
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* Drug: Furosemide Injection
* Drug: Albumin Human


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Furosemide (Lasix) alone<br>Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours | Drug: Furosemide Injection<br>* Patient will receive furosemide intravenously<br>|
| Active Comparator: Combination of furosemide (Lasix) and albumin<br>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<br>* Patient will receive furosemide intravenously<br>Drug: Albumin Human<br>* Patient will receive albumin (25%) 12.5 gm intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight defined as weight loss of 1 kilogram | 2-7 days | 
| Amount of urine | The amount of urine produced over 24 hours. | 2-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum creatinine | Change in renal function | baseline and daily while patient is enrolled in study (2-7 days) | 
| Hospital length of stay | duration of hospital admission | Through completion of study, up to an average of 1 year | 
| 30-day readmission rates | Number of occurrences that the patient is readmitted after discharge within 30 days | 30 days from discharge | 
| Patient survival | Patient survival | 1 year |