Perioperative Glucose Monitoring and Treatment to Reduce Risk of Surgical Site Infections and Complications

NCT06765655 | Enrolling By Invitation

• 2 other identifiers: 23-1221-4STUDY00004617
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Site Infections; Stress Hyperglycemia

Keywords

Hyperglycemia; Surgical Site infections; Insulin lispro sliding scale; Perioperative monitoring

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infections

  Assess for the development of superficial, deep, or organ space infections within 30 days of surgery

  From date of surgery to the end of 30 day postop timeframe

Secondary Outcomes (1)

• Postoperative Complications

  From date of surgery to the end of 30 day postop timeframe

Study Arms (1)

POGM

EXPERIMENTAL

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.

Drug: Insulin Lispro Injection; Diagnostic Test: glucose testing

Interventions

Insulin Lispro Injection DRUG

point-of-care glucose monitoring via fingerstick perioperatively

Also known as: POCT glucose testing

POGM

glucose testing DIAGNOSTIC_TEST

POCT glucose testing via fingerstick

POGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• St. Peter's Hospital, Albany, NY: lead

Study Sites (1)

St. Peter's Hospital

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Hyperglycemia

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jamila Benmoussa, MD

  St. Peter's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cheryl Ernst, MSN, FNP-BC, RNFA

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: April 9, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-09

Locations

US (1)