Status:
RECRUITING
Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sepsis is one of the leading causes of death in intensive care. About 50% of patients with septic shock die after 1 year; and 50% of survivors suffer from cognitive decline. The pathophysiological mec...
Eligibility Criteria
Inclusion
- Age\> 18 years old
- Adult man or woman, hospitalized in intensive care, presenting with sepsis for at least 24 hours according to the diagnostic criteria (Singer et al., 2016).
- Informed consent signed by patient or family member/trusted support person
- In an emergency situation, in the absence of family members/trusted family/trusted support person
Exclusion
- Patient under guardianship or curatorship
- Patient in a severe state of agitation.
- Patient in a state of brain death or active limitation of treatment.
- Multiple trauma patient, with multiple fractures of the skull.
- Refusal to participate in the study or to sign the informed consent by the patient or his loved one,
- Pregnant or breastfeeding woman,
- No affiliation to a social security scheme.
- Patient with cochlear implant
- Patient with heart disease
- Patient with asthma
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04774705
Start Date
March 29 2021
End Date
March 29 2025
Last Update
July 17 2024
Active Locations (1)
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1
Raymond Poincaré Hospital
Garches, France