Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| 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. |
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.