Recruiting

Glucose/Insulin Clamp

Sponsor:

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

Code:

NCT01304290

Conditions

Complication of Transplanted Organ, Nos

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperinsulinemic/normoglycemic clamp

Study Details

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

Conditions

Complication of Transplanted Organ, Nos

Study ID

NCT01304290

Start date

Oct, 2010

Status verified date

Oct, 2013

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: Glucose/Insulin Clamp

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.

Primary outcome measure

  • • 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 ]

Central Contacts and Locations

Central contacts

Ayat Salman, MSc

5149341934ayat.salman@muhc.mcgill.ca

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A1A1

Contacts

Ayat Salman, MSc

5149341934ayat.salman@muhc.mcgill.ca

Principal Investigator:

Dr. Peter Metrakos, MD

More Information

Sponsor

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

Last update posted

Oct 25, 2013

Last verified

Oct, 2013

Keywords

  • inflammatory process
  • hyperglycaemia
  • inflammatory cytokine response
  • organ survival
  • hyperinsulinemic clamp

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2013-10-25.