KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- mortality
研究概览
简要总结
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.
详细描述
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 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
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
- •Adults admitted to ICU and anticipated to require intensive care for at least a few days
排除标准
- •Expected short ICU stay
- •Therapy restricted upon admission
- •Surgical ICU patients
- •Other studies
- •Below 18 years
- •Pregnancy
结局指标
主要结局
mortality
次要结局
- mechanical ventilatory support-dependency
- stay in Intensive Care Unit (ICU)
- stay in hospital
- organ failure
- morbidity
- a long-term follow up is planned to take place 6 and 12 months after hospital discharge
