Clinical Trial: A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

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 Summary:
Sponsor: New York University School of Medicine

Current Primary Outcome: Renal Failure [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: All Cause Mortality [ Time Frame: At any point from time 0 through day 3 ]

Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: April 4, 2014
Date Started: September 2010
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016