Effect of High Dose Insulin on Infectious Complications Following Major Surgery
NCT ID: NCT01528189
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
460 participants
INTERVENTIONAL
2018-10-05
2025-12-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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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
Standard glucose management
Blood glucose levels will be treated by a standard insulin sliding scale.
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.
Hyperinsulinemic normoglycemic clamp
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.
Interventions
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Hyperinsulinemic normoglycemic clamp
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
Blood glucose levels will be treated by a standard insulin sliding scale.
Eligibility Criteria
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Inclusion Criteria
* elective liver, pancreatic or colorectal surgery
* ability to give informed consent
18 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Ralph Lattermann
Assistant Professor, Department of Anesthesia
Principal Investigators
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Ralph Lattermann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesia, McGill University Health Center
Locations
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Royal Victoria Hospital, McGill University Health Centre
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Hospital Clinico Universidad de Chile
Independencia, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2012-01
Identifier Type: -
Identifier Source: org_study_id
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