Overview

Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)

Status:
Unknown status
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Weill Medical College of Cornell University
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- Nonportal hypertensive ascites (i.e. malignancy)

- Hepatic Encephalopathy precluding informed consent