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 — DRUG
    point-of-care glucose monitoring via fingerstick perioperatively
  • glucose testing — DIAGNOSTIC_TEST
    POCT 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: POGM
    Patients 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)

FacilityCityStateZIPSite coordinators
St. Peter's HospitalAlbanyNew York12208-

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