Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT07051694
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-24', 'size': 197298, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T21:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOFA socre', 'timeFrame': 'Baseline and Day 8', 'description': 'The total SOFA score is obtained by adding the scores of the six systems: respiratory, coagulation, liver, cardiovascular, central nervous, and renal. The SOFA score ranges from 0 to 24, with a higher score indicating more severe organ dysfunction.'}], 'secondaryOutcomes': [{'measure': 'blood', 'timeFrame': 'Baseline and Day 8', 'description': 'Routine complete blood count'}, {'measure': 'Glasgow coma scale', 'timeFrame': 'Baseline and Day 8', 'description': 'pecific scoring criteria were established for eye opening, verbal response, and motor response, with maximum scores of 4, 5, and 6 points respectively. A higher score indicating better condition.'}, {'measure': 'tidal volume', 'timeFrame': 'Baseline and Day 8', 'description': 'tested by mechanical ventilation'}, {'measure': 'vasoactive-intropic score', 'timeFrame': 'Baseline and Day 8', 'description': 'VIS can intuitively reflect the degree of dependence of sepsis patients on vasoactive drugs, providing a quantitative indicator for clinicians. It helps to more accurately assess the condition of sepsis, evaluate the therapeutic effect and predict the prognosis. The larger the value, the more severe the condition.'}, {'measure': 'Arterial blood gas (ABG) analysis', 'timeFrame': 'Baseline and Day 8', 'description': 'Arterial blood gas (ABG) analysis'}, {'measure': 'fraction of inspiration O2', 'timeFrame': 'Baseline and Day 8', 'description': 'tested by mechanical ventilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'transcutaneous auricular vagus nerve stimulation'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The goals of this randomized clinical trial are to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standard intensive care on systemic organ function in septic patients, and exploring its potential mechanisms for improving overall outcomes in sepsis.The main question it aims to answer is whether taVNS can reduce the severity of sepsis patients by ameliorating systemic inflammation.Participants will receive standard intensive care treatment and be randomized to receive the taVNS or sham taVNS as adjuvant treatment twice a day for 7 consecutive days. Several evaluations will be done before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-80\n* Sepsis was diagnosed per the Sepsis-3 criteria (SCCM/ESICM 2016) as infection with SOFA score ≥ 2\n* ICU admission within 7 days after sepsis onset\n* Informed consent was obtained from patients/guardians\n\nExclusion Criteria:\n\n* severe ARDS defined by PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O\n* HR\\>120 per minute\n* epinephrine or norepinephrine \\>1ug/kg/min\n* severe underlying pulmonary diseases including interstitial lung disease, -\n* diffuse alveolar hemorrhage, severe asthma, or lung cancer\n* taVNS contraindications: existing pacemakers, cochlear implants, or other active implantable electronic medical devices\n* dermatologic or infectious disorders affecting the auricular region\n* pregnancy or lactation\n* participation in other clinical trials\n* inability to remain motionless during treatment (e.g., due to epilepsy or Parkinson's disease)"}, 'identificationModule': {'nctId': 'NCT07051694', 'acronym': 'TaVNS-Sepsis', 'briefTitle': 'Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Exploratory Study on Transcutaneous Auricular Vagus Nerve Stimulation as Adjuvant Treatment for Sepsis Patients', 'orgStudyIdInfo': {'id': 'AIIT2024050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'taVNS group', 'description': 'transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.', 'interventionNames': ['Device: taVNS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham-taVNS group', 'description': 'sham transcutaneous auricular vagus nerve stimulation twice a day for 7 consecutive days.', 'interventionNames': ['Device: sham-taVNS']}], 'interventions': [{'name': 'taVNS', 'type': 'DEVICE', 'description': 'Transcutaneous Auricular Vagus Nerve Stimulation', 'armGroupLabels': ['taVNS group']}, {'name': 'sham-taVNS', 'type': 'DEVICE', 'description': 'sham transcutaneous auricular vagus nerve stimulation', 'armGroupLabels': ['sham-taVNS group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ethics Committee', 'role': 'CONTACT', 'email': 'xnyyec@sina.com', 'phone': '023-68754035'}], 'facility': 'The First Affiliated Hospital of Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Hong Yang, PhD', 'role': 'CONTACT', 'email': 'YHeasun@163.com', 'phone': '+8618580262250'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org.cn/login.aspx', 'infoTypes': ['ICF'], 'timeFrame': '1year after publishing this research paper', 'ipdSharing': 'YES', 'description': 'ResMan, http://www.medresman.org.cn/login.aspx', 'accessCriteria': 'anyone who are intrested in this research'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Tan Liang', 'investigatorAffiliation': 'Third Military Medical University'}}}}