Spontaneous Bacterial Peritonitis
Conditions
Brief summary
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.
Interventions
DRUGStandard Care
Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
DRUGExperimental
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)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 * Evidence of end stage liver disease / cirrhosis * Documented SBP (ANC \> 250 or positive ascites culture * Ability to provide informed consent * Serum Creatinine \> 1.0 mg/dL and/or Total Bilirubin \> 4.0 mg/dL
Exclusion criteria
* Nonportal hypertensive ascites (i.e. malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Failure | At any point from time 0 through day 3 | Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| All Cause Mortality | At any point from time 0 through day 3 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Administration of Albumin | Throughout Study (72 hours) | The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 1 |
| 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) | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Active Comparator Standard Care | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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
Time frame: At any point from time 0 through day 3
Population: Outcome data was not collected due to logistical challenges of completing the study.
Secondary
All Cause Mortality
Time frame: At any point from time 0 through day 3
Population: Outcome data was not collected due to logistical challenges of completing the study.
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)
Time frame: Throughout Study (72 hours)