Complication of Transplanted Organ, NosNCT01304290
Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
A study testing Hyperinsulinemic/normoglycemic clamp in people with Complication of Transplanted Organ, Nos, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complication of Transplanted Organ, Nos
- What is being tested?
- Hyperinsulinemic/normoglycemic clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Donors must be over 18 years of age
- Brain death donors only
- Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Ayat Salman, MSc, 5149341934 ext. 36237, ayat.salman@muhc.mcgill.ca
Dr. Peter Metrakos, MD
About this study
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
- Being tested
- Hyperinsulinemic/normoglycemic clamp
- Keywords
- inflammatory process, hyperglycaemia, inflammatory cytokine response, organ survival, hyperinsulinemic clamp
- Medical subject headings
- Pyloric Stenosis, Hypertrophic, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic/normoglycemic clampOther
Also called no brand name; its dextrose D20%
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Glucose/Insulin Clamp | Experimental | Not described Receives: Other: Hyperinsulinemic/normoglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: during transplant
Secondary outcomes (1)
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
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Transplanted Organ, NosStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peter metrakos, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Dr. Peter Metrakos, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304290
- Sponsor's protocol ID
- SDR-09-054
- Status last verified
- Oct 2013
- First submitted
- 24 Feb 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose/Insulin Clamp on Solid Organ Transplant (Liver, Kidney, Pancreas and Heart) on Cadaveric Donors
- ClinicalTrials.gov ID
- NCT01304290
- Acronym / sponsor ID
- SDR-09-054
- Conditions
- Complication of Transplanted Organ, Nos
- Keywords
- inflammatory process, hyperglycaemia, inflammatory cytokine response, organ survival, hyperinsulinemic clamp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (estimated)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Glucose/Insulin Clamp | Experimental | Other: Hyperinsulinemic/normoglycemic clamp |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Donors must be over 18 years of age
- Brain death donors only
- Getting consent prior to any specific protocol procedure under Transplant Quebec regulations.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic/normoglycemic clampAlso: no brand name; its dextrose D20%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 | Glucose/Insulin Clamp |
Primary outcome
• Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement.
Time frame: during transplant
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.
1 secondary outcome
Assess organ (heart, liver, pancreas and kidney) survival at one year post-transplant
Time frame: 1 year post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Related trials for Complication of Transplanted Organ, Nos
Active, not recruitingPhase 1
Trial of Regulatory T-cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
Chronic Graft Versus Host Disease, Chronic GVHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Peter Metrakos, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic/normoglycemic clamp in people with Complication of Transplanted Organ, Nos, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayat Salman, MSc (5149341934 ext. 36237, ayat.salman@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Drop in the inflammatory cytokine response after brain death after a minimum of 6 hours therapy with the GICT prior to organ procurement. (time frame: during transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.