NCT Number: NCT01528189
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Royal Victoria Hospital, Montreal, Quebec, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Blood glucose levels will be treated by a standard insulin sliding scale.
Time frame: for 30 days after surgery
Surgical site infections will be defined according to the CDC's NNIS system.
Time frame: 30 days after surgery
Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.
Time frame: for 30 days following surgery
Time frame: for 30 days after surgery
Time frame: the day of hospital discharge
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
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