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A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

NCT02528097 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-07-11

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • Samuel Sigal · NYU MEDICAL CENTER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528097 on ClinicalTrials.gov