- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718575
The Effects of Glucose/Ischemic Preconditioning on Reperfusion Injury in Deceased-Donor Liver Transplantation
A Prospective, Randomized Trial to Investigate the Effects of Glucose/ Ischemic Preconditioning Donor Pre-treatment 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- University Health Network (Toronto General Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Recipient 18 years of age or older
- Recipient with chronic end-stage liver disease
- Deceased donor liver transplant
- Recipient capable of providing written informed consent
- Whole organ graft from donors aged 60 years or older
Exclusion Criteria:
- Fulminant liver failure
- Objection by any other member of the retrieval team
- Split-liver grafts
- Donor that has received total parenteral nutrition within 24hr of organ retrieval Donors from whom the pancreas and/or small bowel are also being retrieved
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
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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.
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No Intervention: 2
Neither donors nor recipients receive any intervention.
All procedures will be performed according to our institution's standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reperfusion injury determined by peak AST
Time Frame: first 24 hours post-operative
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first 24 hours post-operative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biliary Complications, infection and rejection
Time Frame: first month post-transplantation
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first month post-transplantation
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graft and patient survival; length of hospital stay; length of ICU stay
Time Frame: 30 days and 90 days post-transplantation
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30 days and 90 days post-transplantation
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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
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immediately pre-removal and post- transplantation
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Collaborators and Investigators
Investigators
- Principal Investigator: Markus Selzner, M.D., University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-0587-AE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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