Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.
详细描述
Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants underwent cardiac surgery with cardiopulmonary bypass
排除标准
- •Therapy restricted upon admission
- •Preoperative liver or kidney disease or dysfunction
- •Preoperative coagulation disorder
- •Palliative operation or a second operation
- •Type 1 diabetes
- •Type 2 diabetes
结局指标
主要结局
All cause mortality
时间窗: one year
次要结局
- Cardiac Index(average 1 month during the hospitalization)
- Biochemical markers of myocardial injury(troponin and creatine kinase MB)(average 1 month during the hospitalization)
- Acute renal failure(average 1 month during the hospitalization)
- Respiratory failure(average 1 month during the hospitalization)
- ICU and hospital length of stay, and ICU readmissions(average 1 month during the hospitalization)
- Stroke and reversible ischemic neurologic deficit(average 1 month during the hospitalization)
- Inotropic Scores(average 1 month during the hospitalization)
- Perioperative complications(average 1 month during the hospitalization)