Effect of High Dose Insulin on Infectious Complications Following Major Surgery

This study is not yet open for participant recruitment.
Verified February 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01528189
First received: February 3, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention
Surgical Site Infection After Major Surgery
Other: Hyperinsulinemic normoglycemic clamp
Other: Standard glucose management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: for 30 days after surgery ] [ Designated as safety issue: No ]
    Surgical site infections will be defined according to the CDC's NNIS system.


Secondary Outcome Measures:
  • Surgical morbidity [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
    Surgical morbidity in the 30 days following the operation will be assesse as per Clavien score.


Estimated Enrollment: 540
Study Start Date: February 2012
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard glucose management Other: Standard glucose management
Blood glucose levels will be treated by a standard insulin sliding scale.
Active Comparator: Hyperinsulinemic normoglycemic clamp 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528189

Contacts
Contact: Ralph Lattermann, MD PhD 514-934-1934 ext 37023 ralph.lattermann@gmail.com
Contact: Thomas Schricker, MD PhD 514-934-1934 ext 36057 thomas.schricker@mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Ralph Lattermann, MD PhD    514-934-1934 ext 37023    ralph.lattermann@gmail.com   
Contact: Thomas Schricker, MD PhD    514-934-1934 ext 36057    thomas.schricker@mcgill.ca   
Sub-Investigator: George Carvalho, MD MSc         
Sub-Investigator: Roupen Hatzakorzian, MD         
Sub-Investigator: Peter Metrakos, MD         
Sub-Investigator: Prosanto Chaudhury, MD MSc         
Sub-Investigator: Charles Frenette, MD         
Sub-Investigator: Hamed Elgendy, MD PhD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Ralph Lattermann, MD PhD Department of Anaesthesia, McGill University Health Center
  More Information

No publications provided

Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT01528189     History of Changes
Other Study ID Numbers: 2012-01
Study First Received: February 3, 2012
Last Updated: February 7, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McGill University Health Center:
Insulin, surgery, infection

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014