Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

ConditionSeptic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Creteil

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • External Cooling

    Other intervention

    External Cooling

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: Fever Control by external coolingExperimental treatment 1 intervention
Group B: Fever respected, no coolingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mortality

All causes mortality

Time frame
Day 60 from randomization

Secondary outcomes

1

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

Time frame
Up to Day 7
2

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

Time frame
Day 28
3

Number of renal replacement therapy free days

Number of free days will be assessed as proposed by YEHYA et al.

Time frame
Day 28
4

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

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.