Postoperative ComplicationsNCT01001273
Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
A study testing Hyperinsulinemic Normoglycemic Clamp in people with Postoperative Complications, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- 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
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient over 18 years of age
- Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
- Able to give written informed consent prior to any study specific procedure
Who cannot join
- Multi-organ transplant other than kidney transplant
- No central venous access available to deliver the D20W solution
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hospital Royal Victoria
Montreal, Quebec, H3A1A1
Jeanne M Bouteaud, 514.934.1934 ext. 36237, jeanne.bouteaud@muhc.mcgill.ca
Steven Paraskevas, MD, PhD
About this study
This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.
- Conditions
- Postoperative Complications
- Being tested
- Hyperinsulinemic Normoglycemic Clamp
- Keywords
- Pancreas Transplantation, Kidney Transplantation, Organ Transplantation, Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic Normoglycemic ClampOther
The patient receives insulin intravenous infusion at 2ml units/kg/min. Dextrose 20% (D20W ®) will be titrated to maintain blood glucose between 4 - 6 mmol/L (72 - 108 mg/dl).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Hyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days. Receives: Other: Hyperinsulinemic Normoglycemic Clamp |
| Control Group | No intervention | Patients in the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of post-transplants all complications up to 30 days (Clavien grading).
Measured: 30 days post-operative
Secondary outcomes (2)
The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)
Measured: 30 days post-op
The length of hospital stay (days)
Measured: Length of hospital stay (day 1 until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- Collaborators
- Astellas Pharma Canada, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001273
- Sponsor's protocol ID
- SDR-09-061
- Status last verified
- Mar 2011
- First submitted
- 22 Oct 2009
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01001273
- Acronym / sponsor ID
- SDR-09-061
- Conditions
- Postoperative Complications
- Keywords
- Pancreas Transplantation, Kidney Transplantation, Organ Transplantation, Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Astellas Pharma Canada, Inc.
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 26 Oct 2009 (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.
This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Hyperinsulinemic Normoglycemic ClampHyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days. |
| Control Group | No intervention | –Patients in the control group will receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient over 18 years of age
- Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
- Able to give written informed consent prior to any study specific procedure
Key exclusion criteria (2 listed)
- Multi-organ transplant other than kidney transplant
- No central venous access available to deliver the D20W solution
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 ClampThe patient receives insulin intravenous infusion at 2ml units/kg/min. Dextrose 20% (D20W ®) will be titrated to maintain blood glucose between 4 - 6 mmol/L (72 - 108 mg/dl). | Other | Study Group |
Primary outcome
The number of post-transplants all complications up to 30 days (Clavien grading).
Time frame: 30 days post-operative
2 secondary outcomes
The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)
Time frame: 30 days post-op
The length of hospital stay (days)
Time frame: Length of hospital stay (day 1 until discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
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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.
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 Postoperative Complications, 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 2 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 28 Mar 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of post-transplants all complications up to 30 days (Clavien grading). (time frame: 30 days post-operative). 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 28 Mar 2011.