Impact of External Cooling in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
研究概览
简要总结
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.
详细描述
Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.
The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.
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
- •Documented or suspected infection
- •Body temperature > 38.3°C
- •Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure > 65 mmHg.
- •Invasive mechanical ventilation
- •Intravenous sedation
排除标准
- •Temperature > 41°C
- •Age < 18 years
- •Pregnancy
- •Continuous renal replacement therapy
- •Paracetamol or NSAI administration within 6 hours before inclusion
- •Need for paracetamol and/or NSAI therapy during the study period
- •Burns or Lyell syndrome
研究组 & 干预措施
A
干预措施: External cooling (Other)
B
结局指标
主要结局
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
时间窗: 48 hours after enrolment
次要结局
- Maximal dose of vasopressors(within 48 hours after enrolment)
- SOFA score evolution(on Day 3, Day 7, Day 14)
- Number of vasopressor free days in the ICU(during the study)