Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 2:17 AM
Study NCT ID:
NCT04774705
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2021-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'at day 90', 'description': 'Overall death'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of delirium and its duration', 'timeFrame': 'up to day 90'}, {'measure': 'Cumulative incidence of mechanical ventilation and its duration', 'timeFrame': 'up to day 90'}, {'measure': 'Proportion of patients having been the subject of a decision to limit or withdraw care', 'timeFrame': 'at day 90'}, {'measure': 'Duration of use of vasopressors', 'timeFrame': 'at day 90'}, {'measure': 'Number of days alive with a Sequential Organ Failure Assessment Score (SOFA) score <6', 'timeFrame': 'at day 90', 'description': 'Sequential Organ Failure Assessment Score varies from 0 to 4 and permit to assess organ failure. A higher score indicates better neurological function'}, {'measure': 'Length of stay in intensive care and hospitalization in all patients and in survivors', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in C-reactive protein (CRP)', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in fibrinogen level', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in interleukin-6 (IL-6)', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in interleukin-1β (IL-1β)', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in tumor necrosis factor α (TNF-α)', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in the calcium binding protein B S100B (S100B)', 'timeFrame': 'at day 90'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at inclusion'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at day 7'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at day 14'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at day 21'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at day 28'}, {'measure': 'Measurements of changes in the arterial lactate level', 'timeFrame': 'at day 90'}, {'measure': 'Characteristics of the EEG', 'timeFrame': 'at inclusion'}, {'measure': 'Characteristics of the EEG', 'timeFrame': 'at day 7'}, {'measure': 'Mortality rate', 'timeFrame': 'at day 28', 'description': 'Overall death'}, {'measure': 'Neurological fate of patients', 'timeFrame': 'at day 90', 'description': 'Neurological fate of patients will evaluated using Glasgow Outcome Scale (GOS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '40622772', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years old\n* 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).\n* Informed consent signed by patient or family member/trusted support person\n* In an emergency situation, in the absence of family members/trusted family/trusted support person\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* Patient in a severe state of agitation.\n* Patient in a state of brain death or active limitation of treatment.\n* Multiple trauma patient, with multiple fractures of the skull.\n* Refusal to participate in the study or to sign the informed consent by the patient or his loved one,\n* Pregnant or breastfeeding woman,\n* No affiliation to a social security scheme.\n* Patient with cochlear implant\n* Patient with heart disease\n* Patient with asthma'}, 'identificationModule': {'nctId': 'NCT04774705', 'acronym': 'SNV-Sepsis', 'briefTitle': 'Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Randomized Pilot Study Evaluating the Effectiveness of Non-invasive Vagus Nerve Stimulation as an Adjuvant Treatment in Patients With Sepsis in Intensive Care.', 'orgStudyIdInfo': {'id': 'D20170804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )', 'interventionNames': ['Other: SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'For the SNV placebo group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.', 'interventionNames': ['Other: Placebo group']}], 'interventions': [{'name': 'SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )']}, {'name': 'Placebo group', 'type': 'OTHER', 'description': 'For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric AZABOU', 'role': 'CONTACT', 'phone': '+331 47 10 79 40'}], 'facility': 'Raymond Poincaré Hospital', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Eric AZABOU', 'role': 'CONTACT', 'email': 'eric.azabou@aphp.fr', 'phone': '+331 47 10 79 40'}, {'name': 'Matthieu Resche-Rigon', 'role': 'CONTACT', 'email': 'matthieu.resche-rigon@univ-paris-diderot.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}