Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT03393169
Status:
RECRUITING
Last Update Posted:
2018-01-08
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Morbidity and Mortality After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '30 days', 'description': 'All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative organ failure', 'timeFrame': '30 days', 'description': 'Cardiac with inotropic or mechanical support, renal failure or need for dialysis, pulmonary (mechanical ventilation duration), neurologic or digestive complications'}, {'measure': 'Bleeding complications', 'timeFrame': '30 days', 'description': 'Total blood loss, transfusion requirements, surgical reexploration'}, {'measure': 'Arrhythmias', 'timeFrame': '30 days', 'description': 'Atrial fibrillation, ventricular tachycardia'}, {'measure': 'Conductions disturbances', 'timeFrame': '30 days', 'description': 'Need for pace maker implantation'}, {'measure': 'Myocardial injury', 'timeFrame': '30 days', 'description': 'Troponin I release (ng/mL)'}, {'measure': 'Postoperative sepsis', 'timeFrame': '30 days', 'description': 'Pneumonia, septicemia and endocarditis, surgical site infection'}, {'measure': 'Risk score calculation: Euroscore II', 'timeFrame': '30 days', 'description': 'Calculation with all the items required by the published and validated equation'}, {'measure': 'Length of stay', 'timeFrame': '30 days', 'description': 'Length of stay in ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery Under Extra Corporeal Circulation']}, 'descriptionModule': {'briefSummary': 'The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.', 'detailedDescription': "The operative mortality is a key point of the risk-to-benefit ratio analysis before considering cardiac surgery. Operative risk evaluation in a single surgical center is a part of medical care quality assessment. It must be interpreted in the light of the local specificities, in particular the characteristics of the patients and the types of surgery. The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality according to the characteristics of the patients and the type of intervention. study population : inclusion criteria : patient 18 years or older with legal capacity, patients with non-objection to record his/her medical data during hospitalization. Methods: this is an observational prospective and monocentric study. The main objective is to report in-hospital mortality for all types of cardiac surgery performed in Bichat hospital . The secondary objectives are :1) to collect post-operative complications such as hemorrhagic or thromboembolic events or surgery site infections; 2) to analyze mortality rate and post-operative morbidities according to the type of surgery and the main patients' characteristics . 3) to calculate validated and currents risk score such as EuroSCORE I and II for each patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients , 18 years old and older, with a cardiac surgery under extra corporeal circulation in Bichat Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older and has legal capacity - cardiac surgery under extra corporeal circulation\n* non objection to record medical information during hospitalization\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03393169', 'acronym': 'Cardiobase', 'briefTitle': 'Postoperative Morbidity and Mortality After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital', 'orgStudyIdInfo': {'id': 'Cardiobase'}}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'yolande COSTA', 'role': 'CONTACT', 'email': 'yolande.costa@aphp.fr', 'phone': '01 40 25 62 48'}], 'facility': "département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Bernard IUNG, MD.', 'role': 'CONTACT', 'email': 'bernard.Iung@aphp.fr', 'phone': '01 40 25 66 01'}, {'name': 'Sophie PROVENCHERE, MD.', 'role': 'CONTACT', 'email': 'sophie.provenchere@aphp.fr', 'phone': '01 40 25 51 11'}], 'overallOfficials': [{'name': 'Bernard IUNG, MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'with others French University Hospitals (Rennes, Nantes, Paris (PITIE SALPETRIERE) , Bordeaux)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}