Only 38 spots left

~38 spots leftby Dec 2025

High Dose Insulin for Surgical Site Infections

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byRalph Lattermann, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Diabetes, Hypertension, Bipolar, others

Trial Summary

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.

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.¹ ² ³ ⁴ ⁵

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.¹ ² ³ ⁴ ⁶

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.⁷ ⁸ ⁹ ¹⁰ ¹¹

Research Team

Ralph Lattermann, MD PhD

Principal Investigator

Department of Anaesthesia, McGill University Health Center

Eligibility Criteria

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.

I am 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

Hyperinsulinemic normoglycemic clamp (Other)
Standard glucose management (Other)

Trial OverviewThe 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.

Participant Groups

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

Research Locations NearbySelect from list below to view details:

Royal Victoria Hospital, McGill University Health CentreMontreal, Canada

Royal Victoria HospitalMontreal, Canada

Loading ...

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Patients Recruited

170,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose and insulin administration while maintaining normoglycemia during cardiac surgery using a computer-assisted algorithm.Sato, T., Carvalho, G., Sato, H., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative tight glucose control with hyperinsulinemic-normoglycemic clamp technique in cardiac surgery.Sato, H., Carvalho, G., Sato, T., et al.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of normoglycemia during cardiac surgery.Carvalho, G., Moore, A., Qizilbash, B., et al.[2022]

Infusing insulin at doses of 0.20 and 0.15 mU.kg(-1).min(-1) in healthy individuals significantly suppressed glucose production and lowered plasma glucose levels to subphysiological levels, indicating these doses may be excessive for insulin replacement.

The study suggests that the commonly used doses of insulin in the pancreatic clamp technique may need to be reassessed, as lower doses (0.10 mU.kg(-1).min(-1)) did not produce the same effects, highlighting the importance of selecting appropriate hormone doses for accurate biological assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basal insulin, glucagon, and growth hormone replacement.Breckenridge, SM., Raju, B., Arbelaez, AM., et al.[2016]

In a study of pediatric burn patients, those who did not receive insulin had a lower incidence of mortality and shorter hospital stays compared to those who received sliding scale insulin, indicating potential risks associated with insulin treatment in this population.

While insulin administration improved muscle strength and bone mineral content, it also led to increased resting energy expenditure and hypoglycemic episodes, suggesting that alternative glucose management strategies may be necessary for severely burned children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of stress-induced diabetes on outcomes in severely burned children.Finnerty, CC., Ali, A., McLean, J., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of insulin absorption and insulin action.Heinemann, L., Anderson, JH.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin strategies for managing inpatient and outpatient hyperglycemia and diabetes.Moghissi, ES.[2011]

Stress hyperglycemia is linked to a higher risk of surgical site infections (SSIs), but the evidence supporting strict glycemic control to prevent these infections is weak and associated with a risk of hypoglycemia.

Current guidelines for managing blood sugar in surgical patients are based on studies of critically ill patients, highlighting the need for more research to find the best glycemic targets for non-critically ill patients and to explore alternative treatments for stress hyperglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic control and prevention of surgical site infection.Kao, LS., Phatak, UR.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin therapy for the critically ill patient.Van den Berghe, G.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Insulin in the Inpatient Setting: Need for Continued Use.Kumar, S., Molitch, ME.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased insulin requirements are associated with pneumonia after severe injury.Martin, RS., Smith, JS., Hoth, JJ., et al.[2015]