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

Phase 4

Terminated

Conditions: Cirrhosis, Liver
Fluid Overload
Volume Overload

Interventions: Drug: Furosemide Injection
Drug: Albumin Human

Registration Number: NCT04216784

Lead Sponsor: Rush University Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 21

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide (Lasix) alone	Furosemide Injection	Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours
Combination of furosemide (Lasix) and albumin	Furosemide Injection	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
Combination of furosemide (Lasix) and albumin	Albumin Human	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

Primary Outcome Measures

Name	Time	Method
Change in Weight	2-7 days	Change in weight defined as weight loss of 1 kilogram
Amount of Urine	2-7 days	The amount of urine produced over 24 hours.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Creatinine	Through completion of study, up to an average of 1 year	Changes in renal function were observed in patients from the two study arms . Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Hospital Length of Stay	Through completion of study, up to an average of 1 year	duration of hospital admission Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
30-day Readmission Rates	30 days from discharge	Number of occurrences that the patient is readmitted after discharge within 30 days Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.
Patient Survival	1 year	Patient survival rates to be closely monitored in patients from the two study arms Data was not collected for this study. Study was terminated early due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Ultimately this dispute resulted in study termination. At no point before the study was halted was data collected on patients enrolled into the study, nor is data going to be collected in patients that were enrolled into the study.

Trial Locations

Locations (1): Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States