Effect of High Dose Insulin on Infectious Complications Following Major Surgery

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01528189

Collaborator

(none)

540

Enrollment

Locations

Arms

Duration (Months)

180

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection After Major Surgery	Other: Hyperinsulinemic normoglycemic clamp Other: Standard glucose management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.

Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard glucose management	Other: Standard glucose management Blood glucose levels will be treated by a standard insulin sliding scale.
Active Comparator: Hyperinsulinemic normoglycemic clamp	Other: 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.

Arm

Intervention/Treatment

Placebo Comparator: Standard glucose management

Other: Standard glucose management

Blood glucose levels will be treated by a standard insulin sliding scale.

Active Comparator: Hyperinsulinemic normoglycemic clamp

Other: 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.

Outcome Measures

Primary Outcome Measures

Surgical site infection [for 30 days after surgery]
Surgical site infections will be defined according to the CDC's NNIS system.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Hospital, McGill University Health Centre	Montreal	Quebec	Canada	H3A 1A1
2	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A1A1
3	Hospital Clinico Universidad de Chile	Independencia	Santiago	Chile	8380456

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Principal Investigator: Ralph Lattermann, MD PhD, Department of Anaesthesia, McGill University Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ralph Lattermann, Assistant Professor, Department of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT01528189

Other Study ID Numbers:

2012-01

First Posted:

Feb 7, 2012

Last Update Posted:

Nov 20, 2018

Last Verified:

Nov 1, 2018

Keywords provided by Ralph Lattermann, Assistant Professor, Department of Anesthesia, McGill University Health Centre/Research Institute of the McGill University Health Centre

Insulin, surgery, infection

Additional relevant MeSH terms:

Surgical Wound Infection

Study Results

No Results Posted as of Nov 20, 2018