About this trial
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:
1. Respect of fever 2. Fever control at normothermia using external cooling The primary end point will be d-60 mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cardiac arrest within previous 7 days
Acute brain injury within previous 7 days
Extensive burns or epidermal necrolysis
<18 years old
Trial design
Parallel
Treatments tested in this trial
External Cooling
Other interventionExternal Cooling
Treatment groups
Trial outcomes
Primary outcomes
Mortality
All causes mortality
Secondary outcomes
Evolution of SOFA Score
Sequential Organ Failure Assessment (SOFA) score will be calculated at d1, d2, d3 and d7 and compared between the 2 arms. Higer the score higher the severity of organ dysfunctions. Min 0 Max 24
Number of ventilator free days
Number of free days will be assessed as proposed by YEHYA et al. Patients who died before d28 will be considered as having 0 free day
Number of renal replacement therapy free days
Number of free days will be assessed as proposed by YEHYA et al.
Number of vasopressor free days
Number of free days will be assessed as proposed by YEHYA et al. Shock resolution will be defined by vasopressor stop during at least 24h in the absence of care withdrawing
Sponsors and contacts
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