Surgical Site Infection After Major Surgery Clinical Trial
Official title:
Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.
NCT number | NCT01528189 |
Other study ID # | 2012-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 5, 2018 |
Est. completion date | December 2025 |
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).
Status | Recruiting |
Enrollment | 460 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - > 18 years old - elective liver, pancreatic or colorectal surgery - ability to give informed consent Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | Royal Victoria Hospital, McGill University Health Centre | Montreal | Quebec |
Chile | Hospital Clinico Universidad de Chile | Independencia | Santiago |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada, Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical site infection | Surgical site infections will be defined according to the CDC's NNIS system. | for 30 days after surgery | |
Secondary | Surgical morbidity | Surgical morbidity in the 30 days following the operation will be assessed as per Clavien score. | 30 days after surgery |