Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Not Applicable

Recruiting

• Conditions: Surgical Site Infection After Major Surgery
• Interventions: Other: Standard glucose management; Other: Hyperinsulinemic normoglycemic clamp

• Registration Number: NCT01528189
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Study Start: 2018-10-05
• Status Verified: 2024-06
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard glucose management	Standard glucose management	Arterial-blood glucose levels will be checked at induction of anesthesia and every 30 - 60 min thereafter with an StatStrip Xpress® (Nova Biomedical, MA, USA) ( A blood glucose level above 10 mmol/l will be treated with a 2U bolus of IV insulin (Humulin® R regular insulin, Eli Lilly and Company, Indianapolis, IN) followed by a 1 U/hour drip infusion adjusted according to a standard sliding scale
Hyperinsulinemic normoglycemic clamp	Hyperinsulinemic normoglycemic clamp	The blood glucose level will be checked prior to intubation. A 2U bolus of IV insulin will be given if blood glucose level is higher than 6 mmol/l, followed by an IV infusion of 2 U/kg/min (0.12 U/kg/hour). Dextrose 20% (D20W®) will be titrated to maintain blood glucose between 4 and 6 mmol/l. Blood glucose levels will be measured at 5-30 min intervals with a to ensure normoglycemia. At the end of surgery, the insulin infusion will be stopped, and the dextrose infusion weaned off in the post anesthesia care unit.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	for 30 days after surgery	Surgical site infections will be defined according to the CDC's NNIS system.

Secondary Outcome Measures

Name	Time	Method
Surgical morbidity	30 days after surgery	Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.

Trial Locations

Locations (3)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Hospital Clinico Universidad de Chile; 🇨🇱 Independencia, Santiago, Chile

Royal Victoria Hospital, McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada