Cirrhosis, Liver, Volume Overload, Fluid Overload
Conditions
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.
Interventions
Patient will receive furosemide intravenously
DRUGAlbumin Human
Patient will receive albumin (25%) 12.5 gm intravenously
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Furosemide (Lasix) Alone Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours
Furosemide Injection: Patient will receive furosemide intravenously | 0 |
| Combination of Furosemide (Lasix) and Albumin 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
Furosemide Injection: Patient will receive furosemide intravenously
Albumin Human: Patient will receive albumin (25%) 12.5 gm intravenously | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Amount of Urine
The amount of urine produced over 24 hours.
Time frame: 2-7 days
Population: Data were not reported or collected. 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.
Primary
Change in Weight
Change in weight defined as weight loss of 1 kilogram
Time frame: 2-7 days
Population: 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.
Secondary
30-day Readmission Rates
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.
Time frame: 30 days from discharge
Population: 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
Secondary
Change in Serum Creatinine
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.
Time frame: Through completion of study, up to an average of 1 year
Population: 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.
Secondary
Hospital Length of Stay
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.
Time frame: Through completion of study, up to an average of 1 year
Population: 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
Secondary
Patient Survival
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.
Time frame: 1 year
Population: 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