Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT03559569
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Only whole blood will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells.', 'timeFrame': '1 year', 'description': 'Biological samples will be done to evaluate the endothelial and leukocyte senescence.'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states', 'timeFrame': '5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shock', 'Cardiovascular Diseases', 'Infection'], 'conditions': ['Shock', 'Cardiovascular Diseases', 'Infection']}, 'referencesModule': {'references': [{'pmid': '38461810', 'type': 'DERIVED', 'citation': 'Chomel L, Vogt M, Demiselle J, Le Borgne P, Tschirhart M, Morandeau V, Merdji H, Miguet L, Helms J, Meziani F, Mauvieux L. TLRs1-10 Protein Expression in Circulating Human White Blood Cells during Bacterial and COVID-19 Infections. J Innate Immun. 2024;16(1):216-225. doi: 10.1159/000536593. Epub 2024 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.\n\nThe investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.\n\nThe aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted in the intensive care unit of the "Nouvel Hôpital Civil de Strasbourg" for a circulatory shock will be included.\n\nHealthy volunteer will be included in our Clinical Investigation Center of the "Hôpitaux Universitaires de Strasbourg"', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Circulatory shock\n* patient with health care insurance\n\nExclusion criteria:\n\n* Patients' refusal to participate in clinical research\n* Pregnant woman\n* Breastfeeding woman\n* A patient with a protective order"}, 'identificationModule': {'nctId': 'NCT03559569', 'acronym': 'Seneshock', 'briefTitle': 'Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States', 'orgStudyIdInfo': {'id': '7031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with circulatory shock', 'description': '500 patients with circulatory shock hospitalize in ICU will be prospectively included to assess the effect of this pathology on the senescence phenotype', 'interventionNames': ['Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.']}, {'label': 'Healthy volunteers', 'description': '20 healthy volunteers will be included to assess the effect of no pathology on the senescence phenotype.', 'interventionNames': ['Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.']}], 'interventions': [{'name': 'Biological samples will be done to evaluate the endothelial and leukocyte senescence.', 'type': 'BIOLOGICAL', 'description': 'Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.', 'armGroupLabels': ['Healthy volunteers', 'Patients with circulatory shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ferhat MEZIANI', 'role': 'CONTACT', 'email': 'ferhat.meziani@chru-strasbourg.fr', 'phone': '03 69 55 10 24', 'phoneExt': '+33'}, {'name': 'Hamid MERDJI', 'role': 'CONTACT', 'email': 'hamid.merdji@chru-strasbourg.fr', 'phone': '03 69 55 11 23', 'phoneExt': '+33'}, {'name': 'Ferhat MEZIANI', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hamid MERDJI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laure STIEL', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier DELABRANCHE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christine KUMMERLEN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hassène RAHMANI', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra MONNIER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yannick RABOUEL', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie HELMS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raphaël CLERE-JEHL', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dominique STEPHAN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sébastien GAERTNER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine MUTTER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Morgane CLERC', 'role': 'CONTACT', 'email': 'morgane.clerc@chru-strasbourg.fr', 'phone': '03 88 11 68 55', 'phoneExt': '+33'}, {'name': 'Madoé JULIANS', 'role': 'CONTACT', 'email': 'madoe.julians@chru-strasbourg.fr', 'phone': '03 88 11 61 86', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Ferhat MEZIANI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}