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Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of end-stage liver disease with a mortality of up to 10% primarily due to the development of kidney failure. Current standard practice is to treat this infection with broad spectrum antibiotics and salt-poor albumin administration on day one and three of treatment. In this study the investigators test the hypothesis that the administration of a second dose of albumin at 48 hours only to patients with renal insufficiency is as effective at preventing kidney failure as administering the second dose to all patients at 72 hours. In addition, a kidney function determined approach to albumin dosing may lead to substantial cost and resource saving from decreased albumin use without compromising treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator Standard Care | Placebo Comparator | albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) |
|
| Experimental | Experimental | Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Drug | Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Failure | Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours | At any point from time 0 through day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | At any point from time 0 through day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Administration of Albumin | The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours) | Throughout Study (72 hours) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Sigal | NYU MEDICAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator Standard Care | albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) |
| FG001 | Experimental | Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline. Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator Standard Care | albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) |
| BG001 | Experimental |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Renal Failure | Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours | Outcome data was not collected due to logistical challenges of completing the study. | Posted | At any point from time 0 through day 3 |
|
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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 | Active Comparator Standard Care | albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) |
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Due to the extremely small sample size, and the fact that the PI left the institution, no data was analyzed for this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| The Office of Clinical Trials | NYU Langone Medical Center | 646.754.7431 | clinicaltrials@nyumc.org |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Experimental | Drug | 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline) |
|
Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.
Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | All Cause Mortality | Outcome data was not collected due to logistical challenges of completing the study. | Posted | At any point from time 0 through day 3 |
|
|
| Other Pre-specified | Administration of Albumin | The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours) | Not Posted | Throughout Study (72 hours) |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Experimental | Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline. Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline) | 0 | 1 | 0 | 1 |
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