460 Participants Needed

High Dose Insulin for Surgical Site Infections

Recruiting at 2 trial locations
RL
TS
Overseen ByThomas Schricker, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

What You Need to Know Before You Apply

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is high-dose insulin therapy generally safe for humans?

Studies using the hyperinsulinemic-normoglycemic clamp technique in cardiac surgery patients have shown that while it can effectively control blood sugar levels, there is a risk of hypoglycemia (low blood sugar), which is a safety concern.12345

How does the treatment 'High Dose Insulin for Surgical Site Infections' differ from other treatments for this condition?

This treatment uses a method called the hyperinsulinemic normoglycemic clamp, which involves giving high doses of insulin to maintain normal blood sugar levels, potentially reducing the risk of infections after surgery. Unlike standard treatments that may only address high blood sugar when it becomes very elevated, this approach aims for tight control of blood sugar levels to prevent complications.678910

What data supports the effectiveness of the treatment Hyperinsulinemic normoglycemic clamp for surgical site infections?

Research shows that using the hyperinsulinemic-normoglycemic clamp technique during cardiac surgery helps maintain normal blood sugar levels, which is important for reducing complications. This suggests that similar glucose control might help in managing surgical site infections.123411

Who Is on the Research Team?

RL

Ralph Lattermann, MD PhD

Principal Investigator

Department of Anaesthesia, McGill University Health Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for surgery on my liver, pancreas, or colon.
I understand the details of the clinical trial and can consent to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo major abdominal surgery with either standard glucose management or hyperinsulinemic normoglycemic clamp technique

Perioperative period
In-hospital stay

Follow-up

Participants are monitored for surgical site infections and surgical morbidity for 30 days post-surgery

30 days
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperinsulinemic normoglycemic clamp
  • Standard glucose management
Trial Overview 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.
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
476
Recruited
170,000+

Published Research Related to This Trial

In a study of 36 non-diabetic patients undergoing elective cardiac surgery, the computer-guided GIN therapy achieved excellent glycemic control, maintaining blood glucose levels within the target range more effectively than manual control.
The GIN Computer Software (GINCS) resulted in a higher percentage of blood glucose measurements within the target range during surgery, with no instances of hypoglycemia, demonstrating its safety and efficacy in managing glucose levels.
Glucose and insulin administration while maintaining normoglycemia during cardiac surgery using a computer-assisted algorithm.Sato, T., Carvalho, G., Sato, H., et al.[2013]
The study involving 110 patients (70 non-diabetic and 40 diabetic) demonstrated that using a hyperinsulinemic-normoglycemic clamp technique effectively maintained blood glucose levels within the target range during and after cardiac surgery, achieving normoglycemia in 92.8% of non-diabetic and 87.4% of diabetic patients intraoperatively.
The incidence of severe hypoglycemia was very low, at only 2.7% overall, with non-diabetic patients experiencing just 0.2% during surgery, indicating that this method is both effective and safe for managing glucose levels in surgical patients.
Perioperative tight glucose control with hyperinsulinemic-normoglycemic clamp technique in cardiac surgery.Sato, H., Carvalho, G., Sato, T., et al.[2010]
The hyperinsulinemic normoglycemic clamp technique effectively maintained normal blood glucose levels during elective cardiac surgery in both nondiabetic and diabetic patients, achieving significantly better glucose control compared to conventional insulin infusion methods.
In the clamp group, blood glucose levels remained within the target range (4.0-6.0 mmol/L) throughout the surgery, while control group patients experienced hyperglycemia, highlighting the technique's efficacy in preventing perioperative hyperglycemia.
Maintenance of normoglycemia during cardiac surgery.Carvalho, G., Moore, A., Qizilbash, B., et al.[2022]

Citations

Glucose and insulin administration while maintaining normoglycemia during cardiac surgery using a computer-assisted algorithm. [2013]
Perioperative tight glucose control with hyperinsulinemic-normoglycemic clamp technique in cardiac surgery. [2010]
Maintenance of normoglycemia during cardiac surgery. [2022]
Basal insulin, glucagon, and growth hormone replacement. [2016]
Impact of stress-induced diabetes on outcomes in severely burned children. [2021]
Measurement of insulin absorption and insulin action. [2011]
Insulin strategies for managing inpatient and outpatient hyperglycemia and diabetes. [2011]
Glycemic control and prevention of surgical site infection. [2013]
Insulin therapy for the critically ill patient. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Use of Insulin in the Inpatient Setting: Need for Continued Use. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Increased insulin requirements are associated with pneumonia after severe injury. [2015]
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