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

NCT01304290 | Unknown DMC

• 1 other identifier: SDR-09-054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

• Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant

  1 year post-transplant

Study Arms (2)

Control

NO INTERVENTION

Glucose/Insulin Clamp

EXPERIMENTAL

Other: Hyperinsulinemic/normoglycemic clamp

Interventions

Hyperinsulinemic/normoglycemic clamp OTHER

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.

Also known as: no brand name; its dextrose D20%

Glucose/Insulin Clamp

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donors must be over 18 years of age
• Brain death donors only
• Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

RECRUITING

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic; Hyperglycemia

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Peter Metrakos, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayat Salman, MSc

CONTACT

5149341934; ayat.salman@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Multiorgan Transplant Program-MUHC

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2015
• Last Updated: October 25, 2013

Record last verified: 2013-10

Locations

CA (1)