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This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ursodeoxycholic acid | Active Comparator |
| |
| identical-appearing placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ursodeoxycholic acid | Drug | 13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within the first 4 weeks after liver transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-Hai Peng, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10719022 | Background | 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. | |
| 10654358 | 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. |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| identical-appearing placebo | Drug | 13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation |
|
| 7705788 | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |