Effect of High Dose Insulin on Infectious Complications Following Major Surgery
Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- > 18 years old
- elective liver, pancreatic or colorectal surgery
- ability to give informed consent
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Standard glucose management
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
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Blood glucose levels will be treated by a standard insulin sliding scale.
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Active Comparator: Hyperinsulinemic normoglycemic clamp
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical site infection
Time Frame: for 30 days after surgery
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Surgical site infections will be defined according to the CDC's NNIS system.
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for 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical morbidity
Time Frame: 30 days after surgery
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Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.
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30 days after surgery
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Remote site infections
Time Frame: for 30 days following surgery
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for 30 days following surgery
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Bloodstream infections
Time Frame: for 30 days after surgery
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for 30 days after surgery
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Length of hospital stay
Time Frame: the day of hospital discharge
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the day of hospital discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Ralph Lattermann, MD PhD, Department of Anaesthesia, McGill University Health Center
Publications and helpful links
General Publications
- Omiya K, Nakadate Y, Sato H, Koo BW, Schricker T. Accuracy of the Nova StatStrip(R) glucometer in patients undergoing major abdominal surgery: an observational study. Can J Anaesth. 2023 Dec;70(12):1970-1977. doi: 10.1007/s12630-023-02606-z. Epub 2023 Nov 2.
- Omiya K, Sato H, Sato T, Nooh A, Koo BW, Kandelman S, Schricker T. The Quality of Preoperative Glycemic Control Predicts Insulin Sensitivity During Major Upper Abdominal Surgery: A Case-Control Study. Ann Surg Open. 2023 Jan 12;4(1):e234. doi: 10.1097/AS9.0000000000000234. eCollection 2023 Mar.
- Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
- Omiya K, Koo BW, Sato H, Sato T, Kandelman S, Nooh A, Schricker T. Randomized controlled trial of the effect of hyperinsulinemic normoglycemia during liver resection on postoperative hepatic function and surgical site infection. Ann Transl Med. 2023 Mar 15;11(5):205. doi: 10.21037/atm-22-3721.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-01 (AP HM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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