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Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

Not Applicable
Completed
Conditions
Liver Transplantation
Ischemia-reperfusion Injury
Cholestasis
Interventions
Drug: identical-appearing placebo
Registration Number
NCT01073202
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Brief Summary

This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
112
Inclusion Criteria
  • All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment
Exclusion Criteria
  • Age less than 18 years
  • Treatment with UDCA within one month before operation
  • Inability to provide written informed consent prior to study entry
  • Non-liver organ(s) failure prior to entry

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ursodeoxycholic acidursodeoxycholic acid-
identical-appearing placeboidentical-appearing placebo-
Primary Outcome Measures
NameTimeMethod
Serum liver testswithin the first 4 weeks after liver transplantation

Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB)

Secondary Outcome Measures
NameTimeMethod
Postoperative complicationswithin the first 4 weeks after liver transplantation

Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death

Trial Locations

Locations (1)

Shanghai First People's Hospital

🇨🇳

Shanghai, Shanghai, China

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