Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-27 @ 8:56 PM
Study NCT ID:
NCT05412303
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2769}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pourcentage of death', 'timeFrame': 'Day 30'}], 'secondaryOutcomes': [{'measure': '1 - Number of complications', 'timeFrame': 'Day 30', 'description': '1- cardiac, neurological, renal, respiratory, red blood transfusion complication'}, {'measure': '2 - number of days in intensive care', 'timeFrame': 'through study completion, up to 15 days'}, {'measure': '3 - number of days in hospital', 'timeFrame': 'through study completion, up to 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['EMCO-VA']}, 'descriptionModule': {'briefSummary': 'Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.\n\nBased on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post cardiotomy cardiogenic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* Cardiac surgery with cardiopulmonary bypass\n* Post cardiotomy cardiogenic shock\n* ECMO-VA implanted in OR\n\nExclusion Criteria:\n\n* LVAD\n* Heart transplantation\n* Incomplete data in relation to outcomes\n* Cardiac arrest'}, 'identificationModule': {'nctId': 'NCT05412303', 'acronym': 'ECMOVIS', 'briefTitle': 'Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.', 'orgStudyIdInfo': {'id': 'GUINOT 2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With ECMO-VA', 'description': 'postcardiotomy cardiogenic shosck supported by ECMO-VA', 'interventionNames': ['Other: data collection']}, {'label': 'Without ECMO-VA', 'description': 'Post cardiotomy cardiogenic shock medically treated (inotrope and vasopressor)', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'description': 'age, gender, body weight, height, personal medical history, ASA score, EuroSCORE2, type of cardiac surgery, the preoperative left ventricular ejection fraction, the duration of CPB, the duration of aortic clamping, the need for intraoperative blood transfusion, norepinephrine, dobutamine, creatinine value, time to extubation (hours), any occurrence of complications during the stay in the ICU or in the hospital, and the LOS in the ICU and hospital', 'armGroupLabels': ['With ECMO-VA', 'Without ECMO-VA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}