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Albumin Administration

2 for Liver Cirrhosis

Phase 4
Waitlist Available
Led By Samuel H Sigal, MD
Research Sponsored by Weill Medical College of Cornell University
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 duration of hospital admission
Awards & highlights

Study 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.

Eligible Conditions
  • Bacterial Peritonitis
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of hospital admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of hospital admission for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Renal Failure
Secondary outcome measures
Albumin Utilization
All Cause Mortality

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental 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.
Group II: 1Active Control1 Intervention
Standard Care (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?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,215 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
2,546 Patients Enrolled for Liver Cirrhosis
Samuel H Sigal, MDPrincipal InvestigatorNew York Presbyterian Hospital - Cornell/Columbia
Ilan S Weisberg, MDStudy DirectorNew York Presbyterian Hospital - Cornell/Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)
2005. "Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00761098.
All > Cte
~4 spots leftby May 2025
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