A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
- Conditions
- Spontaneous Bacterial Peritonitis
- Interventions
- Drug: Standard CareDrug: Experimental
- Registration Number
- NCT02528097
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- Nonportal hypertensive ascites (i.e. malignancy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator Standard Care Standard Care 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method All Cause Mortality At any point from time 0 through day 3
Trial Locations
- Locations (1)
NYU Langone Medical Center
🇺🇸New York, New York, United States