drugset / Trial / NCT04216784

Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients

NCT04216784

Phase 4 Terminated 21 enrolled Rush University Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-12-19
Primary completion
2023-12-30
Completion
2024-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic 12.5 g Intravenous
Comparator Furosemide Other / unclassified 40 mg Intravenous
Comparator Furosemide Other / unclassified 80 mg Intravenous

Indications