Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
NCT ID: NCT01304290
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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* Prevent hyperglycaemia
* Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
* Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
* Assess graft function by evaluating:
* Liver: post-transplant liver function score (PTLF)
* Kidney: graft function as defined by UNOS (immediate graft function IGF, slow graft function SGF and delayed graft function DGF and
* Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Control
No interventions assigned to this group
Glucose/Insulin Clamp
Hyperinsulinemic/normoglycemic clamp
Dextrose/insulin therapy will start. Dextrose and insulin are given using the so-called "normoglycemic, hyperinsulinemic clamp". Plasma insulin concentration will be increased by a 2ìU/kg/min continuous infusion of insulin. Dextrose will be infused at the rate required to maintain normoglycemia (4-6 mmol/l) until cross clamping of the aorta. The dextrose/insulin therapy will be maintained for a time period of minimum 6 hours.
Interventions
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Hyperinsulinemic/normoglycemic clamp
Dextrose/insulin therapy will start. Dextrose and insulin are given using the so-called "normoglycemic, hyperinsulinemic clamp". Plasma insulin concentration will be increased by a 2ìU/kg/min continuous infusion of insulin. Dextrose will be infused at the rate required to maintain normoglycemia (4-6 mmol/l) until cross clamping of the aorta. The dextrose/insulin therapy will be maintained for a time period of minimum 6 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Brain death donors only
* Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.
Exclusion Criteria
* Time interval between the start of the study and cross-clamping less than 6 hours.
* No solid organs retrieved for transplantation
* Diagnosed with Type 1 Diabetes
* Donor has uncontrolled serum blood glucose levels (above 10 mmol/L) at time of inclusion
18 Years
75 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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peter metrakos
Director Multiorgan Transplant Program-MUHC
Principal Investigators
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Dr. Peter Metrakos, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Ayat Salman, MSc
Role: primary
Other Identifiers
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SDR-09-054
Identifier Type: -
Identifier Source: org_study_id