Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

> 18 years old

elective liver, pancreatic or colorectal surgery

ability to give informed consent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperinsulinemic normoglycemic clamp

    Other intervention

    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.

  • Standard glucose management

    Other intervention

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

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Standard glucose managementPlacebo comparator 1 intervention
Group B: Hyperinsulinemic normoglycemic clampActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical site infection

Surgical site infections will be defined according to the CDC's NNIS system.

Time frame
for 30 days after surgery

Secondary outcomes

1

Surgical morbidity

Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

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