The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Myocardial Function: Left Ventricular Global Longitudinal Strain (%)
研究概览
简要总结
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with standard glucose management.
详细描述
Specific Aim #1:To determine whether intraoperative use of HNC affords cardioprotective benefits measured by improved echocardiographic measures of myocardial function, serum markers of cardiomyocyte injury, and hemodynamic indices measured immediately (at end of surgery) and during the short-term (initial hospitalization).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 - 84 years old, Aortic stenosis, Scheduled for Aortic valve replacement.
排除标准
- •Poor quality echocardiographic images unsuitable for analysis
- •Off -pump surgical procedure
- •Anticipated deep hypothermic circulatory arrest
- •Any contraindications to transesophageal echocardiogram (TEE) or other proposed intervention
- •Unable to give written informed consent (non-English speaking, vulnerable patients, etc.)
研究组 & 干预措施
hyperinsulinemic normoglycemic clamp (HNC)
Patients will be randomized to receive treatment with HNC during cardiac surgery.
干预措施: hyperinsulinemic normoglycemic clamp (HNC) (Other)
standard glucose management
Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.
干预措施: control group (Other)
结局指标
主要结局
Myocardial Function: Left Ventricular Global Longitudinal Strain (%)
时间窗: end of surgery (closure), an average of 5 minutes
Left ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values (%) mean a worse outcome.
Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate
时间窗: end of surgery (closure) an average of 5 minutes
Left ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values mean a worse outcome
次要结局
- Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain(end of surgery (closure) an average of 5 minutes)
- Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate(end of surgery (closure) an average of 5 minutes)