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

July 15, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Garches, France
        • Recruiting
        • Raymond Poincaré Hospital
        • Contact:
          • Eric AZABOU
          • Phone Number: +331 47 10 79 40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )
Other: 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.
Placebo Comparator: Control group
For the SNV placebo group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.
Other: Placebo group
For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: at day 90
Overall death
at day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative incidence of delirium and its duration
Time Frame: up to day 90
up to day 90
Cumulative incidence of mechanical ventilation and its duration
Time Frame: up to day 90
up to day 90
Proportion of patients having been the subject of a decision to limit or withdraw care
Time Frame: at day 90
at day 90
Duration of use of vasopressors
Time Frame: at day 90
at day 90
Length of stay in intensive care and hospitalization in all patients and in survivors
Time Frame: at day 90
at day 90
Measurements of changes in C-reactive protein (CRP)
Time Frame: at inclusion
at inclusion
Measurements of changes in C-reactive protein (CRP)
Time Frame: at day 7
at day 7
Measurements of changes in C-reactive protein (CRP)
Time Frame: at day 14
at day 14
Measurements of changes in C-reactive protein (CRP)
Time Frame: at day 21
at day 21
Measurements of changes in C-reactive protein (CRP)
Time Frame: at day 28
at day 28
Measurements of changes in C-reactive protein (CRP)
Time Frame: at day 90
at day 90
Measurements of changes in fibrinogen level
Time Frame: at inclusion
at inclusion
Measurements of changes in fibrinogen level
Time Frame: at day 7
at day 7
Measurements of changes in fibrinogen level
Time Frame: at day 14
at day 14
Measurements of changes in fibrinogen level
Time Frame: at day 21
at day 21
Measurements of changes in fibrinogen level
Time Frame: at day 28
at day 28
Measurements of changes in fibrinogen level
Time Frame: at day 90
at day 90
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at inclusion
at inclusion
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at day 7
at day 7
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at day 14
at day 14
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at day 21
at day 21
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at day 28
at day 28
Measurements of changes in interleukin-6 (IL-6)
Time Frame: at day 90
at day 90
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at inclusion
at inclusion
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at day 7
at day 7
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at day 14
at day 14
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at day 21
at day 21
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at day 28
at day 28
Measurements of changes in interleukin-1β (IL-1β)
Time Frame: at day 90
at day 90
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at inclusion
at inclusion
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at day 7
at day 7
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at day 14
at day 14
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at day 21
at day 21
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at day 28
at day 28
Measurements of changes in tumor necrosis factor α (TNF-α)
Time Frame: at day 90
at day 90
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at inclusion
at inclusion
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at day 7
at day 7
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at day 14
at day 14
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at day 21
at day 21
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at day 28
at day 28
Measurements of changes in the calcium binding protein B S100B (S100B)
Time Frame: at day 90
at day 90
Measurements of changes in the arterial lactate level
Time Frame: at inclusion
at inclusion
Measurements of changes in the arterial lactate level
Time Frame: at day 7
at day 7
Measurements of changes in the arterial lactate level
Time Frame: at day 14
at day 14
Measurements of changes in the arterial lactate level
Time Frame: at day 21
at day 21
Measurements of changes in the arterial lactate level
Time Frame: at day 28
at day 28
Measurements of changes in the arterial lactate level
Time Frame: at day 90
at day 90
Characteristics of the EEG
Time Frame: at inclusion
at inclusion
Characteristics of the EEG
Time Frame: at day 7
at day 7
Mortality rate
Time Frame: at day 28
Overall death
at day 28
Number of days alive with a Sequential Organ Failure Assessment Score (SOFA) score <6
Time Frame: at day 90
Sequential Organ Failure Assessment Score varies from 0 to 4 and permit to assess organ failure. A higher score indicates better neurological function
at day 90
Neurological fate of patients
Time Frame: at day 90
Neurological fate of patients will evaluated using Glasgow Outcome Scale (GOS)
at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D20170804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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