Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-02 @ 5:00 PM
Study NCT ID:
NCT03327493
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Refractory cardiogenic shock patients under ECLS. Assessment at ECLS start, day 3 and Day "ECLS weaning" for various biological variables'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-15', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-10-26', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)', 'timeFrame': 'day 0 (ECLS initiation), day 3, day "ECLS weaning"', 'description': 'Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)'}], 'secondaryOutcomes': [{'measure': 'Change in hemodynamic parameters', 'timeFrame': 'day 0 (ECLS initiation), day 3, day "ECLS weaning"', 'description': 'Arterial pressures'}, {'measure': 'Change in hemodynamic parameters', 'timeFrame': 'day 0 (ECLS initiation), day 3, day "ECLS weaning"', 'description': 'heart rate'}, {'measure': 'Change in hemodynamic parameters', 'timeFrame': 'day 0 (ECLS initiation), day 3, day "ECLS weaning"', 'description': 'cumulated doses of catecholamines'}, {'measure': 'Cardiac output variation during a weaning ECLS procedure', 'timeFrame': 'day 3, day "ECLS weaning"', 'description': 'At a constant mean arterial pressure (65-75 mmHg), measurement by echocardiography of cardiac output at 2 times:\n\n* baseline (3L/min of ECLS flow)\n* after 45 min at weaning output (1.5 L/min of ECLS flow) Variation of norepinephrine doses will be also recorded'}, {'measure': 'Mortality', 'timeFrame': '28 days and 90 days'}, {'measure': 'Change in TH1 and TH2 pattern', 'timeFrame': 'day 0 (ECLS initation), day 3, day "ECLS weaning"', 'description': 'Assessment in CD3/CD4 + cells of INF γ; IL12 (TH1) and IL4 (TH2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiogenic shock', 'Extra-Corporeal-Life-Support (ECLS)', 'inflammation', 'adrenergic system'], 'conditions': ['Shock, Cardiogenic', 'Extra-Corporeal-Life-Support ( ECLS)', 'Autonomic Nervous System Diseases', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.', 'detailedDescription': 'NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in ICU\n* Refractory cardiogenic shock\n\n * Cardiogenic shock: Systolic Arterial Pressure \\<90mmHg, or Mean Arterial Pressure \\<65mmHg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index \\< 2.2 l/min/m2)\n * Refractory state: hypo responsiveness to norepinephrine AND/OR persisting profound hypo perfusion clinical symptoms despite optimal resuscitation\n* needing an Extra-Corporeal-Life-Support\n* informed consent from relatives or patient\n* Affiliation to a social security regimen\n* Preliminary medical examination\n\nExclusion Criteria:\n\n* Patients under ECLS for a/an :\n\n * Cardiotoxic poisoning\n* Human immunodeficient Virus or Viral hepatitis C\n* Patient \\< 18 yo\n* Pregnancy\n* Patient under protective supervision'}, 'identificationModule': {'nctId': 'NCT03327493', 'acronym': 'ADRECMO', 'briefTitle': 'Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': '2016-A00707-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Refractory cardiogenic shock under ECLS', 'interventionNames': ['Diagnostic Test: Biological']}], 'interventions': [{'name': 'Biological', 'type': 'DIAGNOSTIC_TEST', 'description': 'We will assess in all patients under ECLS for the treatment of a cardiogenic shock at day 0 (ECLS initiation) day 3 and day "ECLS weaning" :\n\nBiological assessment:\n\n1. Adrenoreceptors α1, α2, β1, β2, β3 on monocytes and lymphocytes T helper by flow cytometry\n2. Lymphocytes Th1/Th2 pattern by flow cytometry\n3. Cytokines on plasma : Interleukin (IL) 4, IL 12, TNF α, INF γ , IL1, IL6, IL10\n\nClinical assessment:\n\n1. Hemodynamic parameters\n2. Cumulated doses of catecholamines\n3. Cardiac output variation measured by echocardiography during a standardized weaning procedure of ECLS at a constant mean arterial pressure (only on day 3 and Day "ECLS weaning")', 'armGroupLabels': ['Refractory cardiogenic shock under ECLS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Antoine Kimmoun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PU-PH', 'investigatorFullName': 'Dr Antoine KIMMOUN', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}