Effect of High Dose Insulin on Infectious Complications Following Major Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014