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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
peter metrakos, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01304290
First received: February 24, 2011
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention
Complication of Transplanted Organ, Nos
Other: Hyperinsulinemic/normoglycemic clamp

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant [ Time Frame: 1 year post-transplant ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Glucose/Insulin Clamp Other: 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.
Other Name: no brand name; its dextrose D20%

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304290

Contacts
Contact: Ayat Salman, MSc 5149341934 ext 36237 ayat.salman@muhc.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Ayat Salman, MSc    5149341934 ext 36237    ayat.salman@muhc.mcgill.ca   
Principal Investigator: Dr. Peter Metrakos, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Dr. Peter Metrakos, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: peter metrakos, Director Multiorgan Transplant Program-MUHC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01304290     History of Changes
Other Study ID Numbers: SDR-09-054
Study First Received: February 24, 2011
Last Updated: October 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
inflammatory process
hyperglycaemia
inflammatory cytokine response
organ survival
hyperinsulinemic clamp

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014