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Effect of High Dose Insulin on Infectious Complications Following Major Surgery

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ClinicalTrials.gov Identifier: NCT01528189
Recruitment Status : Recruiting
First Posted : February 7, 2012
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ralph Lattermann, McGill University Health Center

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).


Condition or disease Intervention/treatment Phase
Surgical Site Infection After Major Surgery Other: Hyperinsulinemic normoglycemic clamp Other: Standard glucose management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
Study Start Date : February 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: for 30 days after surgery ]
    Surgical site infections will be defined according to the CDC's NNIS system.


Secondary Outcome Measures :
  1. Surgical morbidity [ Time Frame: 30 days after surgery ]
    Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Ralph Lattermann, MD PhD    514-934-1934 ext 35802    ralph.lattermann@muhc.mcgill.ca   
Contact: Thomas Schricker, MD PhD    514-934-1934 ext 36057    thomas.schricker@mcgill.ca   
Principal Investigator: Ralph Lattermann, MD PhD         
Sub-Investigator: Thomas Schricker, MD PhD         
Sub-Investigator: George Carvalho, MD MSc         
Sub-Investigator: Peter Metrakos, MD         
Sub-Investigator: Linda Wykes, PhD         
Sub-Investigator: Mazen Hassanain, MD         
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: Roupen Hatzakorzian, MD         
Sub-Investigator: Peter Metrakos, MD         
Sub-Investigator: Prosanto Chaudhury, MD MSc         
Sub-Investigator: Charles Frenette, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Ralph Lattermann, MD PhD Department of Anaesthesia, McGill University Health Center

Responsible Party: Ralph Lattermann, Assistant Professor, Department of Anesthesia, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01528189     History of Changes
Other Study ID Numbers: 2012-01
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs