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

Rush

Status and phase: Terminated; Phase 4

Conditions: Cirrhosis, Liver; Fluid Overload; Volume Overload

Treatments: Drug: Albumin Human; Drug: Furosemide Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04216784

19092507-IRB01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

Furosemide (Lasix) alone

Active Comparator group

Description:

Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours

Treatment:

Drug: Furosemide Injection

Combination of furosemide (Lasix) and albumin

Active Comparator group

Description:

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

Treatment:

Drug: Furosemide Injection

Drug: Albumin Human