Clinical Trials Directory

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UnknownNCT01304290

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERHyperinsulinemic/normoglycemic clampDextrose/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.

Timeline

Start date
2010-10-01
Primary completion
2015-01-01
First posted
2011-02-25
Last updated
2013-10-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01304290. Inclusion in this directory is not an endorsement.