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The study halted prematurely due to staffing.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide (Lasix) alone | Active Comparator | Cohort 1 will receive furosemide (Lasix) 40 to 80 mg IVP BID for at least 48 hours |
|
| Combination of furosemide (Lasix) and albumin | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide Injection | Drug | Patient will receive furosemide intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change in weight defined as weight loss of 1 kilogram | 2-7 days |
| Amount of Urine | The amount of urine produced over 24 hours. | 2-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Lance Lineberger, PharmD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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. Study was anticipated to be prospective randomization for inclusion with data being collected retrospectively
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Combination of Furosemide (Lasix) and Albumin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Change in weight defined as weight loss of 1 kilogram | 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. | Posted | 2-7 days |
|
Study terminated due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Resulting in study termination."0" denotes that patient data was not collected. Data not collected due to study termination early due to IRB halting study. At no point was data on patients enrolled into the study, nor is data going to be collected in patients that were enrolled. Study was anticipated to be prospective randomization for inclusion with data being collected retrospectively
Study terminated due to IRB halting study inclusion and data collection due to drug cost (albumin) funding. Resulting in study termination."0" denotes that patient data was not collected. Data not collected due to study termination early due to IRB halting study. At no point was data on patients enrolled into the study, nor is data going to be collected in patients that were enrolled. Study was anticipated to be prospective randomization for inclusion with data being collected retrospectively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lance Lineberger | Rush University Medical Center | 312-942-5126 | Lance_Lineberger@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2019 | Jan 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2020 | Jan 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000075462 | Serum Albumin, Human |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Albumin Human | Drug | Patient will receive albumin (25%) 12.5 gm intravenously |
|
| Through completion of study, up to an average of 1 year |
| 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. | Through completion of study, up to an average of 1 year |
| 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. | 30 days from discharge |
| 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. | 1 year |
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
| BG002 | Total | Total of all reporting groups |
| No |
|
| Age, Continuous |
| Sex: Female, Male | No |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
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 |
|
| Primary | Amount of Urine | The amount of urine produced over 24 hours. | 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. | Posted | 2-7 days |
|
|
| 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. | 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. | Posted | Through completion of study, up to an average of 1 year |
|
|
| 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. | 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 | Posted | Through completion of study, up to an average of 1 year |
|
|
| 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. | 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 | Posted | 30 days from discharge |
|
|
| 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. | 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 | Posted | 1 year |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |