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

McGill University

Status: Unknown

Conditions: Complication of Transplanted Organ, Nos

Treatments: Other: Hyperinsulinemic/normoglycemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT01304290

SDR-09-054

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Control

No Intervention group

Glucose/Insulin Clamp

Experimental group

Treatment:

Other: Hyperinsulinemic/normoglycemic clamp