NCT02528097

A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spontaneous Bacterial Peritonitis

Interventions

Type	Name	Description
DRUG	Standard Care	Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
DRUG	Experimental	25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline)

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-08-19
• Last updated: 2016-07-11
• Results posted: 2016-07-11

Locations

1 site across 1 country: United States