Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT04204694
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of the activated interferon-α receptors (IFNAR) by circulant endothelial cells', 'timeFrame': 'Within 12 hours following the onset of norepinephrin for septic shock (day 1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (\\> 30%).\n\nSeptic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.\n\nTherefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.\n\nThus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.\n\nConcerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will have two groups :\n\n1. Patients with septic shock hospitalized in the ICU from Strasbourg University Hospital\n2. Controls: blood donors recruited by the French blood establishment', 'healthyVolunteers': False, 'eligibilityCriteria': '* For all subjects\n* Age \\> 18 years old\n* For females: negative pregnancy test\n* Subject covered by health insurance\n* Written consent\n* Patients with septic shock\n* Patients must be in ICU\n* Septic shock defined by the Sepsis-3 criteria \\[1\\]\n* Inclusion within the 12 hours following the onset of norepinephrin\n* Controls :\n* Blood donors\n\nExclusion criteria:\n\n* Moribund\n* Age \\< 18 years old\n* Absence of written consent'}, 'identificationModule': {'nctId': 'NCT04204694', 'acronym': 'INTERSEP', 'briefTitle': 'Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock', 'orgStudyIdInfo': {'id': '7350'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient in septic shock', 'interventionNames': ['Other: 3-time blood sampling for septic shock patients']}, {'label': 'blood donor tests', 'interventionNames': ['Other: Only one blood sampling for controls patients']}], 'interventions': [{'name': '3-time blood sampling for septic shock patients', 'type': 'OTHER', 'description': '15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock', 'armGroupLabels': ['Patient in septic shock']}, {'name': 'Only one blood sampling for controls patients', 'type': 'OTHER', 'description': '15 mL blood are sampled from a blood donation', 'armGroupLabels': ['blood donor tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de réanimation médicale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}