Perioperative Glucose Monitoring and Treatment to Reduce Risk of Surgical Site Infections and Complications
Part of paid clinical trials in Albany, New York.
- Sponsor
- St. Peter's Hospital, Albany, NY
- Study ID
- NCT06765655
- Status
- Enrolling By Invitation
Conditions
- Stress Hyperglycemia
- Surgical Site Infections
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Insulin Lispro Injection — DRUGpoint-of-care glucose monitoring via fingerstick perioperatively
- glucose testing — DIAGNOSTIC_TESTPOCT glucose testing via fingerstick
Study Details
This study is to determine if glucose monitoring and treatment in surgical procedures over 2 hours help to decrease the surgical site infection risk and reduce postoperative complications. The study uses a preoperative HgBA1C to place patient into a sliding scale insulin category to be used only if the patient has a blood sugar over 150mg/dL during surgery. This is consistent with the CDC recommendation to keep perioperative glucose below 200 mg/dL in surgical patients. The protocol continues for at least 48 hours to treat stress hyperglycemia in non-diabetic patients, and to closely monitor \& treat glucose levels in diabetic patients.
Key Dates
- Start date
- Apr 9, 2024
- Status verified
- Sep 2024
- Primary completion
- Jan 31, 2025
- Completion
- Jan 31, 2025
Study Design
- Enrollment
- 266 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: POGMPatients will have preoperative Hemoglobin A1C and monitoring of blood glucose every 2 hours during their surgery. If the blood glucose rises over 150 mg/dL, insulin lispro will be administered per sliding scale protocol based on their A1C. Monitoring continues for 48 hours with treatment per protocol as needed.
Primary Outcome Measure
Surgical Site Infections [ Time Frame: From date of surgery to the end of 30 day postop timeframe ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Peter's Hospital | Albany | New York | 12208 | - |
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