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Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Primary Purpose

Surgical Site Infection After Major Surgery

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hyperinsulinemic normoglycemic clamp
Standard glucose management
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection After Major Surgery focused on measuring Insulin, surgery, infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years old
  • elective liver, pancreatic or colorectal surgery
  • ability to give informed consent

Exclusion Criteria:

Sites / Locations

  • Royal Victoria Hospital, McGill University Health CentreRecruiting
  • Royal Victoria Hospital
  • Hospital Clinico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard glucose management

Hyperinsulinemic normoglycemic clamp

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Surgical site infection
Surgical site infections will be defined according to the CDC's NNIS system.

Secondary Outcome Measures

Surgical morbidity
Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.

Full Information

First Posted
February 3, 2012
Last Updated
May 30, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01528189
Brief Title
Effect of High Dose Insulin on Infectious Complications Following Major Surgery
Official Title
Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection After Major Surgery
Keywords
Insulin, surgery, infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard glucose management
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Hyperinsulinemic normoglycemic clamp
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hyperinsulinemic normoglycemic clamp
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard glucose management
Intervention Description
Blood glucose levels will be treated by a standard insulin sliding scale.
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infections will be defined according to the CDC's NNIS system.
Time Frame
for 30 days after surgery
Secondary Outcome Measure Information:
Title
Surgical morbidity
Description
Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years old elective liver, pancreatic or colorectal surgery ability to give informed consent Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Lattermann, MD PhD
Phone
514-934-1934
Ext
37023
Email
ralph.lattermann@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Schricker, MD PhD
Phone
514-934-1934
Ext
36057
Email
thomas.schricker@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Lattermann, MD PhD
Organizational Affiliation
Department of Anaesthesia, McGill University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Lattermann, MD PhD
Phone
514-934-1934
Ext
35802
Email
ralph.lattermann@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Thomas Schricker, MD PhD
Phone
514-934-1934
Ext
36057
Email
thomas.schricker@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Ralph Lattermann, MD PhD
First Name & Middle Initial & Last Name & Degree
Thomas Schricker, MD PhD
First Name & Middle Initial & Last Name & Degree
George Carvalho, MD MSc
First Name & Middle Initial & Last Name & Degree
Peter Metrakos, MD
First Name & Middle Initial & Last Name & Degree
Linda Wykes, PhD
First Name & Middle Initial & Last Name & Degree
Mazen Hassanain, MD
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Lattermann, MD PhD
Phone
514-934-1934
Ext
37023
Email
ralph.lattermann@gmail.com
First Name & Middle Initial & Last Name & Degree
Thomas Schricker, MD PhD
Phone
514-934-1934
Ext
36057
Email
thomas.schricker@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Roupen Hatzakorzian, MD
First Name & Middle Initial & Last Name & Degree
Peter Metrakos, MD
First Name & Middle Initial & Last Name & Degree
Prosanto Chaudhury, MD MSc
First Name & Middle Initial & Last Name & Degree
Charles Frenette, MD
Facility Name
Hospital Clinico Universidad de Chile
City
Independencia
State/Province
Santiago
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela B Advis, M.D.
Phone
+5629788211
Email
dbravoadvis@uchile.cl

12. IPD Sharing Statement

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Effect of High Dose Insulin on Infectious Complications Following Major Surgery

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