NCT01069146已完成不适用
Mild Therapeutic Hypothermia During Severe Sepsis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- feasibility of hypothermia induction during sepsis
研究概览
简要总结
Objectives: to evaluate the feasibility, the safety and the effects on physiological parameters of mild therapeutic hypothermia during septic shock.
Design: a randomized, controlled, pilot physiological study. Setting: a 15-beds university-affiliated intensive care unit of a teaching Hospital.
Patients: twenty ventilated and sedated adults patients with septic shock Intervention: Mild therapeutic hypothermia between 32 and 34°C during 36 consecutive hours using an external water cooling blanket.
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
- None
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
- •age > 18-yrs,
- •sedation and mechanical ventilation for at least 48-hrs,
- •the diagnosis of septic shock according to standard guidelines.
排除标准
- •bradycardia < 50 bpm, or any severe ventricular rhythm disturbances,
- •pregnancy,
- •need for emergent surgery or any other complementary exam involving patient transport within the sixth hours following inclusion,
- •decision to withdraw or withhold life support,
- •predictable death within six hours.
结局指标
主要结局
feasibility of hypothermia induction during sepsis
时间窗: 48 hours
次要结局
- hemodynamic parameters evolution(48 hours)
研究者
研究点 (2)
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