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

NCT04774705 | Recruiting

• 1 other identifier: D20170804
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Overall death

  at day 90

Secondary Outcomes (52)

• Cumulative incidence of delirium and its duration

  up to day 90

• Cumulative incidence of mechanical ventilation and its duration

  up to day 90

• Proportion of patients having been the subject of a decision to limit or withdraw care

  at day 90

• Duration of use of vasopressors

  at day 90

• Number of days alive with a Sequential Organ Failure Assessment Score (SOFA) score <6

  at day 90

Study Arms (2)

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

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Other: Placebo group

Interventions

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

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

Placebo group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Raymond Poincaré Hospital

Garches, France

RECRUITING

Related Publications (1)

• Goggins E, Inoue H, Okusa MD. Neuroimmune Control of Inflammation in Acute Kidney Injury and Multiorgan Dysfunction. J Am Soc Nephrol. 2025 Dec 1;36(12):2473-2484. doi: 10.1681/ASN.0000000813. Epub 2025 Jul 7.

  PMID: 40622772 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Eric AZABOU

CONTACT

+331 47 10 79 40; eric.azabou@aphp.fr

Matthieu Resche-Rigon

CONTACT

+33142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: March 29, 2021
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

FR (1)