Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Nosocomial Infection
研究概览
简要总结
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
详细描述
Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 15 years
- •cardiac surgery with cardiopulmonary bypass
排除标准
- •active infection
- •insulin allergy
- •off-pump cardiopulmonary bypass procedures
研究组 & 干预措施
Tight glycaemic control (TGC)
TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
干预措施: TGC (Drug)
Conventional glycaemic control (Control)
Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
干预措施: Conventional glycaemic control (Drug)
结局指标
主要结局
Nosocomial Infection
时间窗: within the first 30 day after surgery
Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.
次要结局
- Morbidities and All Causes Mortality(within the first 30 days after surgery)
研究者
Panthila Rujirojindakul
Assistant Professor
Prince of Songkla University