Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Episodes of hypoglycemia
研究概览
简要总结
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.
详细描述
Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subarachnoid hemorrhage
- •Traumatic brain injury
- •Intracranial hemorrhage
排除标准
- 未提供
研究组 & 干预措施
A
Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl
干预措施: Insulin (Actrapid) (Drug)
B
Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl
干预措施: Insulin (Actrapid) (Drug)
结局指标
主要结局
Episodes of hypoglycemia
次要结局
- Infection rate(during the study)
- Vasospasm rate(during the study)
- Mortality(6 months follow up)
- Neurologic status(6 months follow up)