Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-02 @ 8:14 PM
Study NCT ID:
NCT03345758
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2017-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-17', 'studyFirstSubmitDate': '2017-10-15', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': 'August,1,2017-March,1,2020', 'description': 'survival rate at discharge'}], 'secondaryOutcomes': [{'measure': 'Quality of live', 'timeFrame': 'August,1,2017-March,1,2020', 'description': 'Questionnaire：mobility，personal care (washing/dressing)，usual activities，Pain/discomfort，Anxiety/depression'}, {'measure': 'Cognitive function', 'timeFrame': 'August,1,2017-March,1,2020', 'description': 'MMSE Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory failure, circulatory failure'], 'conditions': ['Long-term Outcome', 'Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.', 'detailedDescription': "Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* require extracorporeal membrane oxygenation\n\nExclusion Criteria:\n\n* irreversible disease'}, 'identificationModule': {'nctId': 'NCT03345758', 'acronym': 'ECMO', 'briefTitle': 'Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;', 'orgStudyIdInfo': {'id': '20170717'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO mode,outcome', 'description': 'ECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation', 'interventionNames': ['Other: outcome']}], 'interventions': [{'name': 'outcome', 'type': 'OTHER', 'description': 'telephone to patients to finish SF-36 (the MOS item short from health survey,SF-36)，EQ-5D(EuroQol-5 Dimensions,EQ-5D)， AMT-4（Abbreviated Mental Test-4,AMT-4）and MMSE（Mini-mental State Examination,MMSE） to make assessments of their physical and mental health, cognitive function and social adaptation after discharge', 'armGroupLabels': ['ECMO mode,outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Liu, MD.', 'role': 'CONTACT', 'email': 'liuling6600@yahoo.com', 'phone': '86-25-83272201'}, {'name': 'Haibo Qiu, PhD.,MD.', 'role': 'CONTACT', 'email': 'haiboq2200@yahoo.com', 'phone': '86-25-83272200'}, {'name': 'Ling Liu, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Zhong-Da Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'ling liu, MD', 'role': 'CONTACT', 'email': 'liulingdoctor@126.com', 'phone': '13851435472'}], 'overallOfficials': [{'name': 'Haibo Qiu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}