Intraoperative Glucose Monitoring for Diabetes and Stress Hyperglycemia to Reduce Risk of Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Surgical Site Infections
研究概览
简要总结
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.
详细描述
Background
Diabetes and variations in glucose control are comorbidities that increase complications in the surgical patient (Harris, 2018). Insulin signaling is impaired during surgery and transient insulin resistance develops. Decreased circulating insulin levels lead to a physiological hyperglycemic response that lasts 24 to 48 hours after surgery. Surgeries involving the chest and abdomen have a longer and more pronounced degree of hyperglycemia reaction in the body (Peacock, 2019). The prevalence of surgical site infections (SSIs) in surgical patients across the United States has gained significant attention as preventable healthcare infections from the Centers for Disease Control and Prevention (CDC) in recent years. A stratified list supporting this evidence was published by the CDC in 1999 titled Prevention of Surgical Site Infection and is the accepted practice guideline for preventing SSIs (Berrios-Torres et al., 2017). The CDC directs surgical specialties to reduce perioperative glycemic control protocol targets to less than 200 mg/dl for all surgical patients to reduce SSIs (Sermkasemskin et al., 2022). Similar evidence-based guidelines were published by the World Health Organization (WHO) and the American College of Surgeons (ACS) (Camperlengo et al., 2023). Nearly six years after these strong guidelines were published, there is still limited evidence that SSI prevention activities are being followed (Camperlengo et al., 2023).
Perioperative stress hyperglycemia is underestimated because of its presumed lower incidence rate compared to diabetes. The rise in patients presenting to surgical facilities with impaired fasting glucose and/or insulin resistance varies from 23 to 60%.
Stress hyperglycemia is summarized as increased glycogenolysis, insulin resistance, and excessive gluconeogenesis in response to neuroendocrine triggers of stress stimulated by the hypothalamic-pituitary-adrenal axis, sympathoadrenal system receptors, and proinflammatory cytokines. The cytokines are tumor necrosis factor-α, interleukin (IL)-1, and IL-6 (Sermkasemsin et al., 2022). Risk factors for stress hyperglycemia include unknown diabetes, a high American Society of Anesthesiologists (ASA) risk score, long surgical duration, blood transfusion, and intraoperative hypotension (Sermkasemskin et al., 2022).
Purpose
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any adult surgical patient who undergoes a procedure expecting to last 2 or more hours regardless of age, gender, race, sex, religion, nation of origin, or other identifiable demographics -
排除标准
- •Type 1 Diabetes or other patients with strick endocrinology orders
研究组 & 干预措施
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.
干预措施: Insulin Lispro Injection (Drug)
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.
干预措施: glucose testing (Diagnostic Test)
结局指标
主要结局
Surgical Site Infections
时间窗: From date of surgery to the end of 30 day postop timeframe
Assess for the development of superficial, deep, or organ space infections within 30 days of surgery
次要结局
- Postoperative Complications(From date of surgery to the end of 30 day postop timeframe)
研究者
Cheryl Ernst
Cheryl Ernst, MSN, FNP-BC, RNFA
St. Peter's Hospital, Albany, NY
