Ischemic Preconditioning of Liver in Cadaver Donors
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Ischemic Preconditioning of Liver in Cadaver Donors|
- Changes in INR/PT and serum AST, ALT and TB levels [ Time Frame: Values immediately post-transplantation and on days 1 - 3 and days 7, 14 and 30 post-transplantation ] [ Designated as safety issue: No ]
- Plasma levels of cytokines [ Time Frame: Blood samples are collected at pre-incision of abdomen, cross-clamp of abdominal aorta; 3 hour postreprofusion and post-transplant day one in the recipient ] [ Designated as safety issue: No ]
- Interstitial and alveolar edema in chest radiographs [ Time Frame: days 1 - 3 post transplant ] [ Designated as safety issue: No ]
- Length of Hospital stay [ Time Frame: number of days from Liver transplant to hospital discharge on average 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||March 2007|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
No Intervention: No Hepatic Ischemic Preconditioning
donor will act as a sham control.
Experimental: Hepatic Ischemic Preconditioning
blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.
Procedure: Ischemic Preconditioning
Experimental: Hepatic Ischemic Preconditioning blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245830
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|Principal Investigator:||Baburao Koneru, M.D.||UMDNJ-New Jersey Medical School|