Experimental for Bacterial Peritonitis

N/A

Waitlist Available

Led By Samuel Sigal

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study (72 hours)

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.

Eligible Conditions

Bacterial Peritonitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study (72 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study (72 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study (72 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kidney Failure

Other study objectives

Albumins

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr \> 1.0 or BUN or Cr are above baseline.

Group II: Active Comparator Standard CarePlacebo Group1 Intervention

albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental

2008

Completed Phase 2

~2200

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