Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-05 @ 1:32 PM
Study NCT ID:
NCT03695718
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2018-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1057}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1-year', 'description': 'One year survival'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28-day', 'description': 'Mortality on the 28th day'}, {'measure': '28-day CPC', 'timeFrame': '28-day', 'description': 'Brain function at 28th day'}, {'measure': '6-month CPC', 'timeFrame': '6-month', 'description': 'Brain function at 6-month'}, {'measure': '1-year CPC', 'timeFrame': '1-year', 'description': 'Brain function at 1-year'}, {'measure': 'Organ support treatment (mechanical ventilation)', 'timeFrame': 'Hospital discharge (non-survivors) or 1-year (survivors)', 'description': 'Mechanical ventilation'}, {'measure': 'Organ support treatment (renal replacement therapy)', 'timeFrame': 'Hospital discharge (non-survivors) or 1-year (survivors)', 'description': 'Renal replacement therapy'}, {'measure': 'ICU length of stay', 'timeFrame': 'Hospital discharge (non-survivors) or 1-year (survivors)', 'description': 'ICU length of stay'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Hospital discharge (non-survivors) or 1-year (survivors)', 'description': 'Hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Out-Of-Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.', 'detailedDescription': 'This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments.\n\nRegistered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sustained ROSC from OHCA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria:\n\n 1. Sustained ROSC from OHCA at pre-hospital level\n 2. Sustained ROSC from OHCA at the ED of the participating hospitals after ACLS\n 3. Patients sustained ROSC from OHCA and transferred from other hospital to the ED of the participating hospitals for post-cardiac arrest care\n\nExclusion Criteria:\n\n* Age less than 20 years old\n* Patients with advanced directives not to deliver aggressive organ supportive management'}, 'identificationModule': {'nctId': 'NCT03695718', 'briefTitle': 'Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': '16-2013-157'}}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jonghwan Shin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Boramae Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Hwan Shin', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}