Trial Outcomes & Findings for Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients (NCT NCT04216784)
NCT ID: NCT04216784
Last Updated: 2025-09-16
Results Overview
Change in weight defined as weight loss of 1 kilogram
TERMINATED
PHASE4
21 participants
2-7 days
2025-09-16
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compare the Diuretic Effect With Furosemide vs Furosemide and Albumin Combined in Cirrhotic Patients
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 2-7 daysPopulation: 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.
Change in weight defined as weight loss of 1 kilogram
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2-7 daysPopulation: 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.
The amount of urine produced over 24 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of study, up to an average of 1 yearPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through completion of study, up to an average of 1 yearPopulation: 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
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days from dischargePopulation: 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
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: 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 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.
Outcome measures
Outcome data not reported
Adverse Events
Furosemide (Lasix) Alone
Combination of Furosemide (Lasix) and Albumin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place