Complication of Transplanted Organ, Nos
Conditions
Keywords
inflammatory process, hyperglycaemia, inflammatory cytokine response, organ survival, hyperinsulinemic clamp
Brief summary
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
Interventions
OTHERHyperinsulinemic/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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant | 1 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 |
Countries
Canada
Contacts
Primary ContactAyat Salman, MSc
Outcome results
None listed