Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care. (SNV-Sepsis)

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Septic Shock

Sepsis

Treatments

Other: SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )

Other: Placebo group

Study type

Interventional

Funder types

Other

Identifiers

NCT04774705

D20170804

Details and patient eligibility

About

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 mechanisms of serious complications of sepsis are now well known. In fact, the systemic inflammation related to sepsis amplifies the release of pro-inflammatory cytokines and neurotoxic mediators, hence an increase in deleterious phenomena such as oxidative stress, mitochondrial dysfunction, endothelial activation, disruption of the blood-brain barrier, neuroinflammation (astrocytic and microglial activation) leading to multi-organ failure which compromises the patient's vital and functional prognosis. Although there has been progress in the understanding of its pathophysiology, the management of sepsis and septic shock in intensive care relies mainly on anti-infective treatments and the restoration of cardiovascular and respiratory functions. There is virtually no adjuvant therapy for the management of sepsis, apart from a few hormonal therapies such as insulin to maintain blood glucose levels below 180 mg / dL and low doses of corticosteroids and vasopressin. There is therefore a pressing need to develop innovative treatments targeting inflammatory and immunological processes in order to reduce the complications of sepsis and improve patient prognosis. Some recent work has shown that electrical vagus nerve stimulation (SNV), a technique used for the treatment of drug-resistant epilepsy, can modulate inflammatory and immune responses and control inflammation syndrome in animal models of sepsis, arthritis and rheumatism in humans. In this pilot study the investigators plan to evaluate the efficacy of transcutaneous (non-invasive) SNV as an adjuvant treatment in patients with sepsis in intensive care.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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