RecruitingNot ApplicableNCT01528189

Effect of High Dose Insulin on Infectious Complications Following Major Surgery

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


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

460 participants

Start Date

Oct 5, 2018

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

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Interventions

OTHERHyperinsulinemic 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.

OTHERStandard glucose management

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


Locations(3)

Royal Victoria Hospital, McGill University Health Centre

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Hospital Clinico Universidad de Chile

Independencia, Santiago Metropolitan, Chile

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NCT01528189


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