Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:13 PM
Study NCT ID:
NCT04875260
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Center of Outcome and Resource Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003422', 'term': 'Critical Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'mortality status at 30 days after admission to intensive care unit'}], 'secondaryOutcomes': [{'measure': 'Length of stay in intensive care units', 'timeFrame': 'a median 2 to 7 days', 'description': 'Number of days in intensive care unite'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The main purpose of this proposal is to build a multicenter de-identification adult intensive care units database in Taiwan. In future, the Joint Data Management Committee and investigators can use the data for evaluation of outcome of critical care, evaluation of medical resource, quality improvement, annual report, education and training, and critical care research.\n\nCenter of Outcome and Resource Evaluation (CORE) Adult Patient Database of Australian and New Zealand Intensive Care Society (ANZICS) was founded in 1992. More than 160 intensive care units in Australia and New Zealand contribute the data into this database. This database provides medical information to Australia and New Zealand government for critical care policy making and quality improvement. The primary aim of this proposal is to build a multicenter de-identification adult intensive care units database by mutual collaboration of multiple hospitals in Taiwan. This database will include the de-identification data accruing to the regulation of Health Insurance Portability and Accountability Act (HIPAA) of United States of America from each hospital. The data can be used to help the government and critical care societies evaluate the clinical outcomes of critical care. Furthermore, this data can help to effectively allocate the medical resource, improve quality, conduct multicenter registry-based clinical research, and publish high quality research. Hope to assist Taiwan and the world to improve critical care quality.', 'detailedDescription': 'The main purpose of this proposal is to build a multicenter de-identification adult intensive care units database in Taiwan. In future, the Joint Data Management Committee and investigators can use the data for evaluation of outcome of critical care, evaluation of medical resource, quality improvement, annual report, education and training, and critical care research.\n\nCenter of Outcome and Resource Evaluation (CORE) Adult Patient Database of Australian and New Zealand Intensive Care Society (ANZICS) was founded in 1992. More than 160 intensive care units in Australia and New Zealand contribute the data into this database. This database provides medical information to Australia and New Zealand government for critical care policy making and quality improvement. The primary aim of this proposal is to build a multicenter de-identification adult intensive care units database by mutual collaboration of multiple hospitals in Taiwan. This database will include the de-identification data accruing to the regulation of Health Insurance Portability and Accountability Act (HIPAA) of United States of America from each hospital. The data can be used to help the government and critical care societies evaluate the clinical outcomes of critical care. Furthermore, this data can help to effectively allocate the medical resource, improve quality, conduct multicenter registry-based clinical research, and publish high quality research. Hope to assist Taiwan and the world to improve critical care quality.\n\nThe Taiwan Society of Critical Care Medicine, Taiwan Society of Emergency and Critical Care Medicine, and National Taiwan University Hospital invite multiple hospitals to build the multicenter de-identification adult intensive care units database. This database includes only de-identification data. A Joint Data Management Committee will be organized and be in charge of data management. The data will be used for evaluation of outcome of critical care, evaluation of medical resource, quality improvement, and publication of mutual collaboration of critical care research in research ethic committee approved research filed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients admitted to intensive care units', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •Critically ill patients admitted to intensive care units\n\nExclusion Criteria:\n\n* •Critically ill patients admitted to intensive care units'}, 'identificationModule': {'nctId': 'NCT04875260', 'briefTitle': 'Taiwan Center of Outcome and Resource Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Taiwan Center of Outcome and Resource Evaluation Adult Intensive Care Units Database', 'orgStudyIdInfo': {'id': '202006006RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Patients received critical care in the intensive care units', 'interventionNames': ['Other: Critical Care']}], 'interventions': [{'name': 'Critical Care', 'type': 'OTHER', 'description': 'Critical care in the intensive care units', 'armGroupLabels': ['Critically ill patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Hong Chou', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital Yun-Lin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}, {'city': 'Kaohsiung City', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Ju Tsai, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wei-Chun Huang, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'New Taipei City', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hou-Tai Chang, MD', 'role': 'CONTACT'}], 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chieh-Liang Wu', 'role': 'CONTACT'}], 'facility': 'Taichung Veteran General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chin-Ming Chen', 'role': 'CONTACT'}], 'facility': 'Chi Mei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Li-Kuo Kuo', 'role': 'CONTACT'}], 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Chang Yeh, MD, PhD', 'role': 'CONTACT', 'email': 'tonyyeh@ntuh.gov.tw'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'An-Yi Wang', 'role': 'CONTACT'}], 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuan-Fu Chen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Chang Gung Medical Foundation', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Yu-Chang Yeh, MD, PhD', 'role': 'CONTACT', 'email': 'tonyyeh@ntuh.gov.tw', 'phone': '+886-9-10513711'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}