Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study
研究概览
简要总结
The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type II diabetes mellitus patients (as defined by WHO)
- •Diet, oral hypoglycaemic or insulin therapy
- •Undergoing elective and urgent coronary artery bypass surgery
排除标准
- •Non-diabetics
- •Emergency and redo CABG
- •< 18 years
- •Pregnancy
- •Dialysis-dependence
- •History of CVA/TIA < 6 months
- •Heart valve disease requiring surgery
- •STEMI < 3 months
研究组 & 干预措施
1
Administered with glucose potassium insulin solution to achieve euglycaemia 4.0-6.0 mmol/L
干预措施: Glucose potassium insulin solution (Drug)
结局指标
主要结局
The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study
时间窗: 3 months post CABG
次要结局
- Glycaemic control will be assessed 2 hours pre-operatively and 72 hours post-operatively. Measurement timings will be standardized allowing comparison of glycaemic control during different time-periods.(72 hours post CABG)