Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 820
- 试验地点
- 36
- 主要终点
- Mortality
研究概览
简要总结
The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared:
- Respect of fever
- Fever control at normothermia using external cooling The primary end point will be d-60 mortality.
详细描述
Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen requirements. Fever increases inflammation but reduces viral and bacterial growth. The beneficial effects of active fever control on inflammation have been mainly shown in a context of lung injury. Pneumonia represents the first cause of septic shock in developed countries.
In a pilot study (SEPSISCOOL I), we showed that fever treatment using external cooling significantly increased the resolution of shock, improved organ functions and decreased d-14 mortality. Although reduced, hospital mortality was not significantly different. This study was underpowered to allow conclusion on mortality. A more pronounced beneficial effect was observed among the most severely ill patients with elevated serum lactate level.
Fever treatment is commonly applied in septic patients but its impact on survival remains undetermined.
The main objective of the study is to compare two strategies of fever management in febrile (body temperature > 38.3°C) septic shock patients requiring invasive mechanical ventilation and sedation. These patients will be randomly allocated in two arms:
- Fever respect
- Fever control by external cooling to obtain normothermia during 48 hours
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 either communautary or hospital acquired
- •Septic shock defined by the need for vasopressor and lactate>2 mmol/l despite adequate fluid resuscitation (sepsis-3 definition)
- •Patients under invasive mechanical ventilation
- •Body core temperature>38.3°C
- •Intravenous sedation or opioids
- •Ongoing antimicrobial treatment and/or intervention for infection source control
- •Attending physician confirms clinical equipoise without substantial risk if the patient participates in the trial
- •Informed consent of next of kin/other designated person before inclusion or procedure for inclusion in emergency situation
排除标准
- •Cardiac arrest within previous 7 days
- •Acute brain injury within previous 7 days
- •Extensive burns or epidermal necrolysis
- •<18 years old
- •Body core temperature >41°C
- •Under legal guardianship
- •No affiliation with the French health-care system
- •Pregnancy
- •Participation in another interventional study with mortality as the primary endpoint
- •An investigator's decision not to resuscitate
- •Patient already recruited in the trial
结局指标
主要结局
Mortality
时间窗: Day 60 from randomization
All causes mortality
次要结局
- Number of ventilator free days(Day 28)
- Number of vasopressor free days(Day 28)
- Mortality(Day 28)
- Number of patients with shivering(Day 2)
- Number of patients with at least 1 episode of cardiac arrhythmia(Day 3)
- Secondary acquired nosocomial infections(Day 28)
- Number of patients with ARDS development among patients free of ARDS at inclusion(Up to Day 3)
- Number of renal replacement therapy free days(Day 28)
- Evolution of SOFA Score(Up to Day 7)
- Number of patients with seizure(Day 3)
- Number of patients with hypothermia(Day 3)
- Acute kidney injury in patients free of RRT at inclusion(Up to Day7)