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

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 Overview

• Status: Unknown
• Conditions: Complication of Transplanted Organ, Nos
• Intervention / Treatment: Other: Hyperinsulinemic/normoglycemic clamp

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A1A1
      • Recruiting
      • Royal Victoria Hospital
      • Contact: Ayat Salman, MSc; Phone Number: 36237 5149341934; Email: ayat.salman@muhc.mcgill.ca
      • Principal Investigator: Dr. Peter Metrakos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: no brand name; its dextrose D20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.	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.	during transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 andPancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation	1 year post-transplant

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Dr. Peter Metrakos, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (ESTIMATE): February 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 24, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: organ survival; hyperglycaemia; inflammatory process; inflammatory cytokine response; hyperinsulinemic clamp
• Other Study ID Numbers: SDR-09-054