Overview

A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Status:
Terminated
Trial end date:
2015-01-01
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. 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Criteria
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)