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| Sponsored by: |
University of Medicine and Dentistry New Jersey |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00245830 |
Purpose
The long-term goals of this proposal are to develop clinical protocols of donor preconditioning to improve liver graft function and ameliorate complications of poor graft function after liver transplantation. Achievement of these objectives would improve liver recipient outcomes, increase utilization of livers and alleviate the current critical shortage of livers for transplantation. More stringent liver donor selection intended to decrease the complications of poor graft function conflicts directly with efforts to maximize the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases IRI following hepatic resection in humans.
The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of hepatic ischemic preconditioning in deceased donors would improve liver graft function and decrease injury in the early post transplant period. AIM 2: To test the hypothesis that ischemic preconditioning of deceased donor livers would decrease systemic inflammatory response in liver recipients in the early post transplant period. AIM 3: To examine whether ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary edema and acute rejection and shortens hospital stay.
| Condition | Intervention | Phase |
|
Liver Cirrhosis Liver Transplantation |
Procedure: Ischemic Preconditioning |
Phase II Phase III |
| MedlinePlus related topics: | Cirrhosis Edema Liver Transplantation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Ischemic Preconditioning of Liver in Cadaver Donors |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2003 |
| Study Completion Date: | March 2007 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site.
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |||||
| University Hospital | |||||
| Newark, New Jersey, United States, 07101 | |||||
| University of Medicine and Dentistry New Jersey |
| Principal Investigator: | Baburao Koneru, M.D. | UMDNJ-New Jersey Medical School |
More Information
| Study ID Numbers: | 0120010348 |
| First Received: | October 26, 2005 |
| Last Updated: | April 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00245830 |
| Health Authority: | United States: Institutional Review Board |
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