The Effects of Glucose/Ischemic Preconditioning on Reperfusion Injury in Deceased-Donor Liver Transplantation
Standard liver retrieval procedures for transplantation from a deceased donor inevitably result in a "reperfusion injury" to the liver tissue. The purpose of this research study is to find out whether treatment of the liver with a "preconditioning" protocol before its removal from the donor will help reduce any of this injury.
The "preconditioning" treatment being tested has two components. Firstly, a solution of glucose+insulin is infused and secondly, blood flow to the liver is stopped briefly (10 minutes) and then resumed. Both strategies, individually, have been shown to reduce liver tissue injury in human studies.
We hypothesize that combining both strategies will have a clinical benefit to patients and will improve liver function following transplant.
|Liver Transplantation||Procedure: Glucose/Ischemic Preconditioning Pre-treatment||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized Trial to Investigate the Effects of Glucose/ Ischemic Preconditioning Donor Pre-treatment on Reperfusion Injury in Deceased-Donor Liver Transplantation|
- Reperfusion injury determined by peak AST [ Time Frame: first 24 hours post-operative ]
- Biliary Complications, infection and rejection [ Time Frame: first month post-transplantation ]
- graft and patient survival; length of hospital stay; length of ICU stay [ Time Frame: 30 days and 90 days post-transplantation ]
- Liver ATP and glycogen content; blood cytokine levels; liver gene expression of pro- and anti-apoptotic genes [ Time Frame: immediately pre-removal and post- transplantation ]
|Study Start Date:||August 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Deceased liver donors that are randomized to this arm will receive the Glucose/Ischemic Preconditioning pre-treatment intra-operatively prior to starting cold preservation of the organ
Procedure: Glucose/Ischemic Preconditioning Pre-treatment
A 20% dextrose+insulin infusion is administered to the liver via the mesenteric vein beginning after cannulation of the mesenteric vein and ending immediately prior to flushing with cold preservation fluid. Also, after completion of the visceral dissection but prior to cross-clamping, ischemic precondition will occur. This involves occluding the portal vein and hepatic artery to stop blood flow for 10 minutes, then restoring blood flow for 10 minutes.
No Intervention: 2
Neither donors nor recipients receive any intervention. All procedures will be performed according to our institution's standard of care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718575
|University Health Network (Toronto General Hospital)|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Markus Selzner, M.D.||University Health Network, Toronto|