Effect of High Dose Insulin on Infectious Complications Following Major Surgery

NCT01528189 | Recruiting DMC

• 1 other identifier: 2012-01
• Study Type: interventional
• Target: 460
• Locations: 2 countries
• Sites: 3

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).

Conditions

Surgical Site Infection After Major Surgery

Keywords

Insulin, surgery, infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infections will be defined according to the CDC's NNIS system.

  for 30 days after surgery

Secondary Outcomes (1)

• Surgical morbidity

  30 days after surgery

Study Arms (2)

Standard glucose management

PLACEBO COMPARATOR

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

Other: Standard glucose management

Hyperinsulinemic normoglycemic clamp

ACTIVE COMPARATOR

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.

Other: Hyperinsulinemic normoglycemic clamp

Interventions

Hyperinsulinemic normoglycemic clamp OTHER

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.

Hyperinsulinemic normoglycemic clamp

Standard glucose management OTHER

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

Standard glucose management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (3)

Royal Victoria Hospital, McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

NOT YET RECRUITING

Hospital Clinico Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

NOT YET RECRUITING

Related Publications (4)

• Omiya K, Nakadate Y, Sato H, Koo BW, Schricker T. Accuracy of the Nova StatStrip(R) glucometer in patients undergoing major abdominal surgery: an observational study. Can J Anaesth. 2023 Dec;70(12):1970-1977. doi: 10.1007/s12630-023-02606-z. Epub 2023 Nov 2.

  PMID: 37919630 DERIVED

• Omiya K, Sato H, Sato T, Nooh A, Koo BW, Kandelman S, Schricker T. The Quality of Preoperative Glycemic Control Predicts Insulin Sensitivity During Major Upper Abdominal Surgery: A Case-Control Study. Ann Surg Open. 2023 Jan 12;4(1):e234. doi: 10.1097/AS9.0000000000000234. eCollection 2023 Mar.

  PMID: 37600876 DERIVED

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

• Omiya K, Koo BW, Sato H, Sato T, Kandelman S, Nooh A, Schricker T. Randomized controlled trial of the effect of hyperinsulinemic normoglycemia during liver resection on postoperative hepatic function and surgical site infection. Ann Transl Med. 2023 Mar 15;11(5):205. doi: 10.21037/atm-22-3721.

  PMID: 37007572 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Infections

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ralph Lattermann, MD PhD

  Department of Anaesthesia, McGill University Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph Lattermann, MD PhD

CONTACT

514-934-1934; ralph.lattermann@gmail.com

Thomas Schricker, MD PhD

CONTACT

514-934-1934; thomas.schricker@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesia

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: October 5, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2024-06

Locations

CA (2); CL (1)