Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04620694
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative vasopressor requirement', 'timeFrame': 'end of surgery', 'description': 'Mean intraoperative dosage of Norepinephrine (µg.kg-1.min-1)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery', 'Aortic to radial arterial pressure gradient', 'Vasopressor'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'Choice of arterial cannulation site during cardiac surgery is controversial. Some physicians in our institution prefer radial artery site, others prefer aortic site (via femoral artery or brachial artery). The investigators aim to compare these two strategies for vasopressor requirement. The study hypothesis is that radial artery cannulation is associated with a larger dose of vasopressor due aortic to radial arterial pressure gradient phenomenon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Scheduled for cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* More than one arterial cannula at the beginning of the surgery'}, 'identificationModule': {'nctId': 'NCT04620694', 'acronym': 'ATRAP-GCS', 'briefTitle': 'Impact of Arterial Cannulation Site on Vasopressor Requirement in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Arterial Cannulation Site on Vasopressor Requirement During Cardiac Surgery: a Monocentric Prospective Cohort Study', 'orgStudyIdInfo': {'id': '69HCL20_0947'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radial artery cannulation', 'description': 'Patients whom radial artery was cannulated at the beginning of the surgery.'}, {'label': 'Aortic cannulation (brachial or femoral artery)', 'description': 'Patients whom femoral or brachial artery was cannulated at the beginning of the surgery.\n\nActive comparator', 'interventionNames': ['Device: Choice of arterial cannulation site at the beginning of the surgery']}], 'interventions': [{'name': 'Choice of arterial cannulation site at the beginning of the surgery', 'type': 'DEVICE', 'description': 'Choice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician.', 'armGroupLabels': ['Aortic cannulation (brachial or femoral artery)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Remi Schweizer, MD', 'role': 'CONTACT', 'email': 'remi.schweizer@chu-lyon.fr', 'phone': '0033472318933'}, {'name': 'Jean Luc FELLAHI, MD', 'role': 'CONTACT', 'email': 'jean-luc.fellahi@chu-lyon.fr', 'phone': '0033472318933'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}