NCT06275971Unknown不适用
Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients
Kangbuk Samsung Hospital2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2022年11月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Time within the target range of 100-180 mg/dL
研究概览
简要总结
The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.)
- •Subjects over the age of 18
- •Patients with type 2 diabetes
- •Patients with prediabetes
- •HbA1c 5.7% or more
- •fasting blood glucose 100 mg/dL or more
- •2 hours 75g-OGTT 140 mg/dL or more
排除标准
- •Emergency surgery patients
- •Patients performing co-operation other than cardiac surgery
- •Patients with type 1 diabetes
- •Total Pancreatectomy patients
- •Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more)
- •Patients who do not consent to the study
- •Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)
- •Cases where severe weight gain and severe edema occur after surgery
- •Cases where the surgery time is significantly longer than average
- •Cases where cardiopulmonary bypass is used more than once during surgery
- •Others who are deemed unsuitable for research progression at the researcher's discretion
研究组 & 干预措施
CGM arm
Experimental
Glycemic control was monitored using CGM data for seven days following cardiac surgery
干预措施: Dexcom G6 (Device)
SMBG or venous/arterial glucose arm
Active Comparator
Glycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery
干预措施: SMBG or venous/arterial blood glucose (Device)
结局指标
主要结局
Time within the target range of 100-180 mg/dL
时间窗: 1-7 days after surgery
Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery
次要结局
- Standard Deviation (SD)(1-7 days after surgery)
- Number of days of ICU hospitalization(From 1 day after surgery until the date of ICU discharge or date of death from any cause, whichever came first, asessed up to 30 days)
- Time to reach <54 mg/dL(1-7 days after surgery)
- Time to reach >180 mg/dL(1-7 days after surgery)
- Mean glucose(1-7 days after surgery)
- Mortality within 30 days of surgery(1-30 days after surgery)
- Time within the target range of 100-140 mg/dL(1-7 days after surgery)
- Time to reach <70 mg/dL(1-7 days after surgery)
- Coefficient of variation (CV)(1-7 days after surgery)
- Number of participants with pneumonia occurrence after surgery(1-7 days after surgery)
- Time within the target range of 70-180 mg/dL(1-7 days after surgery)
- Time to reach >250 mg/dL(1-7 days after surgery)
- Number of participants who underwent CRRT implementation after surgery(1-7 days after surgery)
- Number of participants with Atrial fibrillation occurrence after surgery(1-7 days after surgery)
- Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery(1-7 days after surgery)
- Glucose management indicator (GMI)(1-7 days after surgery)
- Number of days hospitalized after surgery(From 1 day after surgery until the date of hospital discharge or date of death from any cause, whichever came first, asessed up to 30 days)
- Number of participants with wound infection occurrence after surgery(1-7 days after surgery)
- Changes in concentration of serum CRP level after surgery(1-7 days after surgery)
研究者
Cheol-Young Park
Professor, MD. PhD
Kangbuk Samsung Hospital, Sungkyunkwan University
研究点 (2)
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