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

Shanghai Jiao Tong University School of Medicine112 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Liver Transplantation Ischemia-reperfusion Injury Cholestasis

Interventions

ursodeoxycholic acidDRUG

13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation

identical-appearing placeboDRUG

13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Serum liver tests

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

Time frame: within the first 4 weeks after liver transplantation

Secondary Outcomes

Postoperative complications

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

Time frame: within the first 4 weeks after liver transplantation

Data from ClinicalTrials.gov

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