Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-05 @ 10:36 PM
Study NCT ID:
NCT03204968
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-06-29', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations', 'timeFrame': '3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day', 'description': 'changes of serum Interleukin (IL-6, IL-10, IL-18, IL-1) concentrations in pg/ml from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of the target interleukins at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response.'}], 'secondaryOutcomes': [{'measure': 'The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations', 'timeFrame': '3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day', 'description': 'changes of serum CRP concentrations in mg/L from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of CRP at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vagus nerve', 'Lung lobectomy'], 'conditions': ['Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '32358638', 'type': 'DERIVED', 'citation': 'Salama M, Akan A, Mueller MR. Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve Attenuates the Acute Inflammatory Response After Lung Lobectomy. World J Surg. 2020 Sep;44(9):3167-3174. doi: 10.1007/s00268-020-05543-w.'}], 'seeAlsoLinks': [{'url': 'https://www.researchgate.net/project/Postsurgical-Trauma-and-inflammatory-response', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lung Lobectomy or pneumonectomy\n* Adult\n* Open surgery\n\nExclusion Criteria:\n\n* Current infection'}, 'identificationModule': {'nctId': 'NCT03204968', 'briefTitle': 'The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy', 'organization': {'class': 'OTHER', 'fullName': 'Otto Wagner Hospital'}, 'officialTitle': 'The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy', 'orgStudyIdInfo': {'id': 'Vagus Stimulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treated', 'interventionNames': ['Device: Vagus nerve stimulation']}], 'interventions': [{'name': 'Vagus nerve stimulation', 'type': 'DEVICE', 'description': 'transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)', 'armGroupLabels': ['Treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Thoracic Surgery, Otto-Wagner Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Mueller, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otto Wagner Hospital'}, {'name': 'Mohamed Salama, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Otto Wagner Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otto Wagner Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mohamed Salama', 'investigatorAffiliation': 'Otto Wagner Hospital'}}}}