Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04330651
Status:
RECRUITING
Last Update Posted:
2021-04-28
First Post:
2020-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-Surgery Extracorporeal Life Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D000080942', 'term': 'Post-Cardiac Arrest Syndrome'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 month after surgery', 'description': 'Evaluate Early, mid and late Survival'}, {'measure': 'Survival', 'timeFrame': 'At 1 Year after surgery', 'description': 'mid-time survival'}, {'measure': 'Survival', 'timeFrame': 'At 5 years after surgery', 'description': 'late survival'}], 'secondaryOutcomes': [{'measure': 'Prognostic factors', 'timeFrame': 'Early: 1 month after surgery', 'description': 'Identify early and late negative and positive prognostic factors'}, {'measure': 'Prognostic Factors', 'timeFrame': 'Late: 5 years after surgery', 'description': 'Identify early and late negative and positive prognostic factors'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extracorporeal life support', 'ecls', 'ecmo', 'outocome', 'prognostic factors', 'extracorporeal membrane oxygenation'], 'conditions': ['Cardiogenic Shock', 'Extracorporeal Life Support', 'Extracorporeal Membrane Oxygenation Complication', 'Post Cardiac Arrest Syndrome', 'Post-cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent cardiac surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent cardiac surgery\n\nExclusion Criteria:\n\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT04330651', 'acronym': 'PC-ECLS', 'briefTitle': 'Post-Surgery Extracorporeal Life Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': "Outcomes' Predictors in Post-Surgery Extracorporeal Life Support", 'orgStudyIdInfo': {'id': 'PC-ECLS Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECLS', 'type': 'PROCEDURE', 'description': 'Emergency application of Extracorporeal Life Support in post-surgical patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50144', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Bonacchi, MD', 'role': 'CONTACT', 'email': 'mbonacchi@unifi.it', 'phone': '393389855782'}, {'name': 'Sandro Gelsomino, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edvin Prifti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aleksander Dokollari, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Massimo Bonacchi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sandro Gelsomino', 'class': 'UNKNOWN'}, {'name': 'Edvin Prifti', 'class': 'UNKNOWN'}, {'name': 'Francesco Cabrucci', 'class': 'UNKNOWN'}, {'name': 'Marco Bugetti', 'class': 'UNKNOWN'}, {'name': 'Orlando Parise', 'class': 'UNKNOWN'}, {'name': 'Aleksander Dokollari', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Massimo Bonacchi', 'investigatorAffiliation': 'University of Florence'}}}}