Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Surgical Site Infection After Major Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01528189
• Other study ID #: 2012-01
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2018
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Ralph Lattermann, MD PhD
• Phone: 514-934-1934
• Email: ralph.lattermann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Surgical Site Infection After Major Surgery
• Surgical Wound Infection

Intervention

Other:
• Hyperinsulinemic normoglycemic clamp
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.
• Standard glucose management
Blood glucose levels will be treated by a standard insulin sliding scale.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital, McGill University Health Centre	Montreal	Quebec
Chile	Hospital Clinico Universidad de Chile	Independencia	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Countries where clinical trial is conducted

Canada,  Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infections will be defined according to the CDC's NNIS system.	for 30 days after surgery
Secondary	Surgical morbidity	Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.	30 days after surgery