Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT06112561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Index, SVR/SVRI During Weaning From ECC- Data Obtained From Femoral and Radial Artery Transducer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-13', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': '5 minutes after weaning from extracorporeal circulation (ECC)', 'description': 'Measurement of cardiac output from radial and femoral arterial cannula'}, {'measure': 'Prediction of hypotension episode (HPI)', 'timeFrame': '5 minutes after weaning from ECC', 'description': 'Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula'}, {'measure': 'Systemic Vascular resistance (SVR)', 'timeFrame': '5 minutes after weaning from ECC', 'description': 'Measurement of SVR from femoral and radial arterial cannula'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac output', 'cardiac index', 'systemic vascular resistance'], 'conditions': ['Coronary Artery Disease', 'Aortic Valve Disease', 'Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'Swan Ganz catheter-Edwards Lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery.\n\nDuring weaning from extracorporeal circulation, arterial waveform-derived cardiac output measurements from radial cannulation site is not reliable as compared with measurements obtained from femoral cannulation site.', 'detailedDescription': '50 consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass, valve replacement or combined surgery are included in the study. Cardiac output is measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation,\n\nExclusion Criteria: none'}, 'identificationModule': {'nctId': 'NCT06112561', 'acronym': 'RaFe', 'briefTitle': 'Cardiac Index, SVR/SVRI During Weaning From ECC- Data Obtained From Femoral and Radial Artery Transducer', 'organization': {'class': 'OTHER', 'fullName': 'George Papanicolaou Hospital'}, 'officialTitle': 'Fluctuation and Realbility of Cardiac Index and SVR/SVRI During Weaning From ECC Regarding Values Obtained From Femoral and Radial Artery Acumen IQ Sensor', 'orgStudyIdInfo': {'id': 'Aqumen23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cardiac output/index/SVR', 'description': 'Record of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula.', 'interventionNames': ['Device: CO/CI/SVR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypotension event', 'description': 'Prevent of hypotension event calculated from radial/femoral artery cannula', 'interventionNames': ['Device: CO/CI/SVR']}], 'interventions': [{'name': 'CO/CI/SVR', 'type': 'DEVICE', 'description': 'fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.', 'armGroupLabels': ['Cardiac output/index/SVR', 'Hypotension event']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Irene Asouhidou, MD,PhD', 'role': 'CONTACT', 'email': 'iasouh@aol.com', 'phone': '00306944740633'}, {'name': 'Theodoros Karaiskos, MD,PhD', 'role': 'CONTACT', 'email': 'theokaraiskos@gmail.com'}], 'overallOfficials': [{'name': 'Olga Ananiadou, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'George PAPANIKOLAOU G.H.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Papanicolaou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Asouhidou Irene', 'investigatorAffiliation': 'George Papanicolaou Hospital'}}}}