High Dose Insulin for Surgical Site Infections

N/A

Recruiting

Led By Ralph Lattermann, MD PhD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing elective liver, pancreatic, or colorectal surgery

Patients must be 18 years old or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Summary

This trial aims to reduce post-op infections in major abdominal surgeries by maintaining normal blood sugar levels.

Who is the study for?

This trial is for adults who are scheduled for elective liver, pancreatic, or colorectal surgery and can give informed consent. It aims to see if managing blood sugar with high-dose insulin during and after surgery can reduce infections at the surgical site.

What is being tested?

The study compares standard glucose management to a technique called hyperinsulinemic normoglycemic clamp, which involves giving insulin and dextrose to maintain normal blood sugar levels during major abdominal surgery.

What are the potential side effects?

Potential side effects may include low blood sugar from the insulin treatment or complications related to maintaining strict glucose levels during surgery. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery on my liver, pancreas, or colon.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 30 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgical site infection

Secondary study objectives

Surgical morbidity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Hyperinsulinemic normoglycemic clampActive Control1 Intervention

The blood glucose level will be checked prior to intubation. A 2U bolus of IV insulin will be given if blood glucose level is higher than 6 mmol/l, followed by an IV infusion of 2 U/kg/min (0.12 U/kg/hour). Dextrose 20% (D20W®) will be titrated to maintain blood glucose between 4 and 6 mmol/l. Blood glucose levels will be measured at 5-30 min intervals with a to ensure normoglycemia. At the end of surgery, the insulin infusion will be stopped, and the dextrose infusion weaned off in the post anesthesia care unit.

Group II: Standard glucose managementPlacebo Group1 Intervention

Arterial-blood glucose levels will be checked at induction of anesthesia and every 30 - 60 min thereafter with an StatStrip Xpress® (Nova Biomedical, MA, USA) ( A blood glucose level above 10 mmol/l will be treated with a 2U bolus of IV insulin (Humulin® R regular insulin, Eli Lilly and Company, Indianapolis, IN) followed by a 1 U/hour drip infusion adjusted according to a standard sliding scale

0 / 2Eligibility criteria met