Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis
Conditions
Brief summary
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.
Interventions
DRUGursodeoxycholic acid
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum liver tests | within 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | within 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 |
Countries
China
Outcome results
None listed