Surgical Site Infection After Major SurgeryNCT01528189
Effect of High Dose Insulin on Infectious Complications Following Major Surgery
A study testing Hyperinsulinemic normoglycemic clamp and Standard glucose management in people with Surgical Site Infection After Major Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection After Major Surgery
- What is being tested?
- Hyperinsulinemic normoglycemic clamp and Standard glucose management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Oct 2018to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- elective liver, pancreatic or colorectal surgery
- ability to give informed consent
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Royal Victoria Hospital, McGill University Health Centre
Montreal, Quebec, H3A 1A1
Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Chile1 site
Hospital Clinico Universidad de Chile
Independencia, Santiago Metropolitan, 8380456
About this study
Official title: 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).
Read the 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.
- Being tested
- Hyperinsulinemic normoglycemic clamp, Standard glucose management
- Keywords
- Insulin, surgery, infection
- Medical subject headings
- Insulin Resistance, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic normoglycemic clampOther
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 managementOther
Blood glucose levels will be treated by a standard insulin sliding scale.
| Study group | Role | What they receive |
|---|---|---|
| Standard glucose management | Placebo comparator | 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 Receives: Other: Standard glucose management |
| Hyperinsulinemic normoglycemic clamp | Active comparator | 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. Receives: Other: Hyperinsulinemic normoglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infections will be defined according to the CDC's NNIS system.
Measured: for 30 days after surgery
Secondary outcomes (4)
Surgical morbidity
Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score.
Measured: 30 days after surgery
Remote site infections
Measured: for 30 days following surgery
Bloodstream infections
Measured: for 30 days after surgery
Length of hospital stay
Measured: the day of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study start5 Oct 2018
- Primary completion1 May 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection After Major SurgeryStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Schricker, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ralph Lattermann, MD PhD, Principal investigator, Department of Anaesthesia, McGill University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528189
- Sponsor's protocol ID
- 2012-01
- Status last verified
- Aug 2026
- First submitted
- 3 Feb 2012
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37919630Omiya 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.
PubMed 37600876Bellon 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.
PubMed 37526194Omiya 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.
PubMed 37007572
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01528189
- Acronym / sponsor ID
- 2012-01
- Keywords
- Insulin, surgery, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 7 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard glucose management | Placebo comparator | Other: Standard glucose managementArterial-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 |
| Hyperinsulinemic normoglycemic clamp | Active comparator | Other: Hyperinsulinemic normoglycemic clampThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- elective liver, pancreatic or colorectal surgery
- ability to give informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperinsulinemic normoglycemic clampPatients 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. | Other | Hyperinsulinemic normoglycemic clamp |
| Standard glucose managementBlood glucose levels will be treated by a standard insulin sliding scale. | Other | Standard glucose management |
Primary outcome
Surgical site infection
Time frame: for 30 days after surgery
Surgical site infections will be defined according to the CDC's NNIS system.
4 secondary outcomes
Surgical morbidity
Time frame: 30 days after surgery
Remote site infections
Time frame: for 30 days following surgery
Bloodstream infections
Time frame: for 30 days after surgery
Length of hospital stay
Time frame: the day of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 37919630Omiya 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.
- Derived from this study: PubMed 37600876Omiya 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.
- Derived from this study: PubMed 37526194Bellon 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.
- Derived from this study: PubMed 37007572Omiya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Lattermann, MD PhD principal investigator
Department of Anaesthesia, McGill University Health Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic normoglycemic clamp and Standard glucose management in people with Surgical Site Infection After Major Surgery, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: for 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01528189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.