Clinical trial NCT01528189: Effect of High Dose Insulin on Infectious Complications Following Major Surgery
Official title: Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Site Infection After Major Surgery
Keywords: Insulin, surgery, infection
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Detailed description: This randomized, open-label, controlled trial will be performed in adult (\>18 years old) patients scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures including liver resections, pancreatectomies, duodenectomies, gastrojejunostomies, choledochojejunostomies and hepaticojejunostomies) at the Royal Victoria Hospital (RVH), McGill University Health Centre (MUHC), Montreal, QC, Canada.

Inclusion criteria: above 18 years old, scheduled for elective open abdominal aortic aneurysm repairs and open hepatobiliary procedures.

Exclusion criteria: inability to give consent, current wound infection, previous surgery at the same site within the preceding 30 days, allergy to insulin.

RECRUITMENT

Initial contact prior to surgery will be made by a research team member not involved in the care of the patient who will explain the research project and obtain written consent.

Consenting patients will then be randomized with the assistance of a computerized randomization system.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
measure: Surgical site infection
timeFrame: for 30 days after surgery
Secondary outcomes:
measure: Surgical morbidity
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital, McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Independencia
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Santiago
Study officials:
affiliation: Department of Anaesthesia, McGill University Health Center
name: Ralph Lattermann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: