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

Complication of Transplanted Organ, Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01304290
• Other study ID #: SDR-09-054
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2011
• Last updated: October 24, 2013
• Start date: October 2010

Study information

• Verified date: October 2013
• Source: McGill University Health Center
• Contact: Ayat Salman, MSc
• Phone: 5149341934
• Email: ayat.salman[@]muhc.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Complication of Transplanted Organ, Nos

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	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 and; Pancreas: 7 day post-transplant insulin requirement, C-peptide and C-RP levels at day one and seven post-transplantation	1 year post-transplant	No