Using high dose insulin to reduce infections after major abdominal surgery
Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
This study is testing if using high doses of insulin can help prevent infections after major abdominal surgeries for adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 3 sites (Montreal, Quebec and 2 other locations) |
| Trial ID | NCT01528189 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether maintaining normoglycemia through a hyperinsulinemic-normoglycemic clamp can reduce the incidence of surgical site infections in patients undergoing major abdominal surgeries, such as liver and pancreatic procedures. The study involves adult patients scheduled for elective surgeries at the Royal Victoria Hospital in Montreal, Canada. Participants will be randomized to receive either the insulin clamp treatment or standard glucose management, with the aim of assessing the effectiveness of this approach in preventing postoperative infections.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective open abdominal aortic aneurysm repairs or hepatobiliary surgeries.
Not a fit: Patients with current wound infections, recent surgeries at the same site, or allergies to insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of surgical site infections, improving recovery outcomes for patients undergoing major abdominal surgeries.
How similar studies have performed: While the approach of using insulin to manage blood glucose levels is established, the specific application of this method to reduce surgical site infections is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 18 years old * elective liver, pancreatic or colorectal surgery * ability to give informed consent Exclusion Criteria:
Where this trial is running
Montreal, Quebec and 2 other locations
- Royal Victoria Hospital, McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Royal Victoria Hospital — Montreal, Quebec, Canada (Not_yet_recruiting)
- Hospital Clinico Universidad de Chile — Independencia, Santiago Metropolitan, Chile (Not_yet_recruiting)
Study contacts
- Principal investigator: Ralph Lattermann, MD PhD — Department of Anaesthesia, McGill University Health Center
- Study coordinator: Ralph Lattermann, MD PhD
- Email: ralph.lattermann@gmail.com
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.