Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-24 @ 3:08 PM
Study NCT ID:
NCT02571920
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3099}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-07', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}], 'secondaryOutcomes': [{'measure': 'Correlation between use of cardiac output monitoring and the incidence of norepinephrine use', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of cardiac output monitoring and the incidence of dobutamine use', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of cardiac output monitoring and the incidence of epinephrine use', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of cardiac output monitoring and the length of norepinephrine infusion', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of cardiac output monitoring and the length of dobutamine infusion', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of cardiac output monitoring and the length of epinephrine infusion', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}, {'measure': 'Correlation between use of of cardiac output monitoring and the incidence of postoperative complications', 'timeFrame': 'Up to 28 days after surgery (length of intensive care unit stay)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'cardiac output'], 'conditions': ['C.Surgical Procedure; Cardiac']}, 'descriptionModule': {'briefSummary': 'Describe the proportion of patients who underwent cardiac surgery in France and benefiting from a monitoring cardiac output, describe the use of positive inotropic and vasoactive agents for cardiac surgery patients operated (type of catecholamines, their duration), describe the fluid replacement and transfusions of first 24 hours, describe the incidence of postoperative complications in patients undergoing cardiac surgery.', 'detailedDescription': 'The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.\n\nHowever, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.\n\nThe investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.\n\nThe main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.\n\nSecondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving elective cardiac surgery during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old undergoing cardiac surgery during the study period\n\nNon-inclusion Criteria:\n\n* age under 18 years old\n* Extracorporeal life support and others cardiac assistance\n* congenital cardiac surgery\n* TAVI procedures\n* Pericardium surgical drainages\n* Sternal sepsis surgery'}, 'identificationModule': {'nctId': 'NCT02571920', 'acronym': 'EMOA', 'briefTitle': 'Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)', 'orgStudyIdInfo': {'id': 'A14-D64-VOL.23'}}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'Marc-Olivier Fischer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}, {'name': 'Fabien Dechanet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}, {'name': "Raphaël D'Orlando", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}