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

NCT01073202 | Completed

• 1 other identifier: SFPH05B41
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplantation; Ischemia-reperfusion Injury; Cholestasis

Outcome Measures

Primary Outcomes (1)

• 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)

  within the first 4 weeks after liver transplantation

Secondary Outcomes (1)

• Postoperative complications

  within the first 4 weeks after liver transplantation

Study Arms (2)

ursodeoxycholic acid

ACTIVE COMPARATOR

Drug: ursodeoxycholic acid

identical-appearing placebo

PLACEBO COMPARATOR

Drug: identical-appearing placebo

Interventions

ursodeoxycholic acid DRUG

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

ursodeoxycholic acid

identical-appearing placebo DRUG

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

identical-appearing placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (3)

• Hertl M, Hertl MC, Kluth D, Broelsch CE. Hydrophilic bile salts protect bile duct epithelium during cold preservation: a scanning electron microscopy study. Liver Transpl. 2000 Mar;6(2):207-12. doi: 10.1002/lt.500060201.

  PMID: 10719022 BACKGROUND

• Hertl M, Hertl MC, Kunkel P, Schilling S, Prevot B, Kluth D, Malago M, Broelsch CE. Tauroursodeoxycholate ameliorates reperfusion injury after pig liver transplantation. Transpl Int. 1999;12(6):454-62. doi: 10.1007/s001470050257.

  PMID: 10654358 BACKGROUND

• Hertl M, Harvey PR, Swanson PE, West DD, Howard TK, Shenoy S, Strasberg SM. Evidence of preservation injury to bile ducts by bile salts in the pig and its prevention by infusions of hydrophilic bile salts. Hepatology. 1995 Apr;21(4):1130-7.

  PMID: 7705788 BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury; Cholestasis

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Zhi-Hai Peng, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: May 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 30, 2010

Record last verified: 2009-12

Locations

CN (1)