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

NCT ID: NCT04774705

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2025-03-29

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 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.

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

A transcutaneous stimulator of the atrial branch of the vagus nerve of the TENS eco Plus type (Schwa-medico) will be used. SNV stimulation will be applied in the concha of the left ear to the subcutaneous area of the atrial branch of the vagus nerve in the left ear (cymba conchae) for each patient, at an intensity of 2 mA, 30 minutes per day for 5 consecutive days, from the day of inclusion / randomization.

Control group

For the SNV placebo group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: OTHER

For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.

Interventions

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

A transcutaneous stimulator of the atrial branch of the vagus nerve of the TENS eco Plus type (Schwa-medico) will be used. SNV stimulation will be applied in the concha of the left ear to the subcutaneous area of the atrial branch of the vagus nerve in the left ear (cymba conchae) for each patient, at an intensity of 2 mA, 30 minutes per day for 5 consecutive days, from the day of inclusion / randomization.

Intervention Type: OTHER

Placebo group

For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Raymond Poincaré Hospital

Garches, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric AZABOU

Role: CONTACT

eric.azabou@aphp.fr

+331 47 10 79 40

Matthieu Resche-Rigon

Role: CONTACT

matthieu.resche-rigon@univ-paris-diderot.fr

+33142499742

Facility Contacts

Eric AZABOU

Role: primary

+331 47 10 79 40

References

Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Jul 7. doi: 10.1681/ASN.0000000813. Online ahead of print.

Reference Type: DERIVED

PMID: 40622772 (View on PubMed)

Other Identifiers

D20170804

Identifier Type: -

Identifier Source: org_study_id