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Albumin Administration

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)
Awards & highlights

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 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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,083 Total Patients Enrolled
Samuel SigalPrincipal InvestigatorNYU MEDICAL CENTER
1 Previous Clinical Trials
~0 spots leftby Oct 2025