Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors

Study Overview
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Brief Summary
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Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can: 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

Official Title
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Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors

Conditions
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Complication of Transplanted Organ, Nos

Intervention / Treatment
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* Other: Hyperinsulinemic/normoglycemic clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors must be over 18 years of age Brain death donors only Getting consent prior to any specific protocol procedure under Transplant Quebec regulations. Exclusion Criteria: Inability to obtain a research consent 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Glucose/Insulin Clamp<br> | Other: Hyperinsulinemic/normoglycemic clamp<br>* 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.<br>* Other names: no brand name; its dextrose D20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement. | Our objective in this study will be to determine if implementing the glucose/insulin clamp (GICT) on cadaveric organ donors can: 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. | during transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant | 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 | 1 year post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory process, hyperglycaemia, inflammatory cytokine response, organ survival, hyperinsulinemic clamp