Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT04967261
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2021-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D000080942', 'term': 'Post-Cardiac Arrest Syndrome'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 529}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'In-hospital mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac arrest', 'post-cardiac arrest syndrome', 'neurological outcome'], 'conditions': ['Cardiology']}, 'descriptionModule': {'briefSummary': "To explore whether the patient's neurological function recovery period is sufficient after successful emergency resuscitation recommended by the current guidelines", 'detailedDescription': 'The research team will collect patient data after successful emergency resuscitation after cardiac arrest in the emergency room of National Taiwan University Hospital, and will collect and analyze the relationship between the time for patients to regain consciousness and drug use, hemodynamic changes, and neurological examination results after resuscitation. To explore whether the patient population needs to extend the observation time of neurological function after a certain CPR emergency treatment, and allow the patient to have a longer observation period to regain consciousness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-traumatic cardiac arrest who have been successfully resuscitated by first aid and admitted to the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-traumatic cardiac arrest in the emergency room of National Taiwan University Hospital (including pre-hospital cardiac arrest and in-hospital cardiac arrest) after successful emergency resuscitation\n\nExclusion Criteria:\n\n* Under 20 years old\n* Pregnant women\n* Those who have not been admitted to the intensive care unit\n* Unconsciousness before the heartbeat stops\n* A clear consciousness after successful first aid resuscitation'}, 'identificationModule': {'nctId': 'NCT04967261', 'briefTitle': 'The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors', 'orgStudyIdInfo': {'id': '202106019RINB'}}, 'contactsLocationsModule': {'locations': [{'zip': 'No. 7', 'city': 'Taipei', 'state': 'Zhongshan South Road', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Min-Shan Tsai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}