Ischemic Preconditioning of Liver in Cadaver Donors
|First Received Date ICMJE||October 26, 2005|
|Last Updated Date||April 27, 2007|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||INR/PT and serum AST, ALT and TB levels|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00245830 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Ischemic Preconditioning of Liver in Cadaver Donors|
|Official Title ICMJE||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.
To accomplish this aim, we will compare interstitial and alveolar edema in chest radiographs done after transplant and on post operative days 1, 2 and 3; biopsy confirmed acute rejection within 30 days post transplant, and number of days to discharge after transplantation in recipients of livers from IPC and No IPC donors.
Research Design A prospective, randomized, and single masked (liver recipients) study will be conducted in one liver transplant center over a period of two years. Deceased liver donors will be randomized in equal proportions to one of two organ recovery procedures: 1). IPC or 2). No IPC. Allocation will be stratified by age < 50 or age >= 50 to facilitate examination of the effects of age on IPC. As the trial will enroll donors over a two-year period, treatment assignments will be balanced over blocks of length 12, 16 and 20, where the length will be selected at random, to control for time varying factors. Recovered livers are transplanted into recipients > 18 years of age. All other aspects of donor management, organ recovery and preservation, recipient selection, graft implantation and post transplant management including immunosuppression will be according to standard practice.
II. Research Methods
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Ischemic Preconditioning|
|Study Arm (s)||Not Provided|
|Publications *||Koneru B, Fisher A, He Y, Klein KM, Skurnick J, Wilson DJ, de la Torre AN, Merchant A, Arora R, Samanta AK. Ischemic preconditioning in deceased donor liver transplantation: a prospective randomized clinical trial of safety and efficacy. Liver Transpl. 2005 Feb;11(2):196-202.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
- Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site.
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00245830|
|Other Study ID Numbers ICMJE||0120010348|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Medicine and Dentistry New Jersey|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Medicine and Dentistry New Jersey|
|Verification Date||March 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP