Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)
Status unconfirmed · Phase 4
Conditions studied: Spontaneous Bacterial Peritonitis, Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT00761098
- Run by
- Weill Medical College of Cornell University
- People needed
- 80
- Starts
- 2005-05-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2011-01-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 75
- End Stage Liver Disease / Cirrhosis
- Documented SBP (ANC > 250 or positive ascites culture)
- Ability to provide informed consent
- Serum Creatinine > 1.0 and/or Total Bilirubin > 4.0
You may not qualify if…
- Nonportal hypertensive ascites (i.e. malignancy)
- Hepatic Encephalopathy precluding informed consent
Where it is running
- New York Presbyterian Hospital - Weill Cornell Medical Center — New York, New York, United States (enrolling)
- New York Presbyterian Hospital - Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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