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

McGill University Health Centre/Research Institute of the McGill University Health Centre20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Complication of Transplanted Organ, Nos

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

• Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.

Time frame: during transplant

Secondary Outcomes

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

Time frame: 1 year post-transplant