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Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01528189
Enrollment
460
Registered
2012-02-07
Start date
2018-10-05
Completion date
2025-12-31
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection After Major Surgery

Keywords

Insulin, surgery, infection

Brief summary

Despite improvements in surgical techniques and perioperative care, the high incidence of postoperative surgical site infections remains a major problem in patients undergoing major abdominal surgery (liver, pancreatic and colorectal surgery). Using the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin combined with dextrose titrated to clamp blood glucose between 4 and 6 mmol/L, we successfully established and preserved normoglycemia during the perioperative period. Our objective of this study is to determine if the maintenance of perioperative normoglycemia by a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space/ surgical site infections following abdominal surgery (liver, pancreatic and colorectal surgery).

Detailed description

This randomized, open-label, controlled trial will be performed in adult (\>18 years old) patients scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures including liver resections, pancreatectomies, duodenectomies, gastrojejunostomies, choledochojejunostomies and hepaticojejunostomies) at the Royal Victoria Hospital (RVH), McGill University Health Centre (MUHC), Montreal, QC, Canada. Inclusion criteria: above 18 years old, scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures. Exclusion criteria: inability to give consent, current wound infection, previous surgery at the same site within the preceding 30 days, allergy to insulin. RECRUITMENT Initial contact prior to surgery will be made by a research team member not involved in the care of the patient who will explain the research project and obtain written consent. Consenting patients will then be randomized with the assistance of a computerized randomization system.

Interventions

Patients will receive an IV infusion of 2 mU/kg/min (0.12 U/kg/hour) starting in the operating room. Dextrose 20% will be titrated to maintain blood glucose between 4 and 6 mmol/l. At the end of surgery, the insulin infusion will be stopped and the dextrose infusion weaned off in the postanesthesia care unit.

OTHERStandard glucose management

Blood glucose levels will be treated by a standard insulin sliding scale.

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 18 years old * elective liver, pancreatic or colorectal surgery * ability to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infectionfor 30 days after surgerySurgical site infections will be defined according to the CDC's NNIS system.

Secondary

MeasureTime frameDescription
Surgical morbidity30 days after surgerySurgical morbidity in the 30 days following the operation will be assessed as per Clavien score.

Countries

Canada, Chile

Contacts

Primary ContactRalph Lattermann, MD PhD
ralph.lattermann@gmail.com514-934-1934
Backup ContactThomas Schricker, MD PhD
thomas.schricker@mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026