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High Dose Insulin for Surgical Site Infections
N/A
Recruiting
Led By Ralph Lattermann, MD PhD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing elective liver, pancreatic, or colorectal surgery
Patients must be 18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after surgery
Awards & highlights
Study Summary
This trial aims to reduce post-op infections in major abdominal surgeries by maintaining normal blood sugar levels.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include low blood sugar from the insulin treatment or complications related to maintaining strict glucose levels during surgery. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery on my liver, pancreas, or colon.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 30 days after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 30 days after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical site infection
Secondary outcome measures
Surgical morbidity
Trial Design
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
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
444 Previous Clinical Trials
159,088 Total Patients Enrolled
Ralph Lattermann, MD PhDPrincipal InvestigatorDepartment of Anaesthesia, McGill University Health Center
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.
Research Study Groups:
This trial has the following groups:- Group 1: Standard glucose management
- Group 2: Hyperinsulinemic normoglycemic clamp
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research require more participants to enroll?
"This medical study, which was first posted on February 1st 2012 and most recently revised November 19th 2018, is not currently enrolling participants. Nevertheless, there are 84 other clinical trials actively recruiting patients now."
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