A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Stopped early · Not applicable

Conditions studied: Spontaneous Bacterial Peritonitis

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. 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.

Key facts

Study ID

NCT02528097

Run by

NYU Langone Health

People needed

2

Starts

2010-09-01

Expected to finish

2015-01-01

Last updated by the study team

2016-07-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Nonportal hypertensive ascites (i.e. malignancy)

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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