Status:
UNKNOWN
Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Spontaneous Bacterial Peritonitis
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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. Curr...
Detailed Description
Spontaneous bacterial peritonitis (SBP), infection of the peritoneal fluid(ascites) without evidence of a surgically treatable source, is a common and frequently fatal complication of patients with en...
Eligibility Criteria
Inclusion
- Age 18 to 75
- End Stage Liver Disease / Cirrhosis
- Documented SBP (ANC \> 250 or positive ascites culture)
- Ability to provide informed consent
- Serum Creatinine \> 1.0 and/or Total Bilirubin \> 4.0
Exclusion
- Nonportal hypertensive ascites (i.e. malignancy)
- Hepatic Encephalopathy precluding informed consent
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00761098
Start Date
May 1 2005
End Date
August 1 2010
Last Update
January 4 2011
Active Locations (2)
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1
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, United States, 10021
2
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States, 10032