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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04875260
Other study ID # 202006006RINA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 2040

Study information

Verified date February 2024
Source National Taiwan University Hospital
Contact Yu-Chang Yeh, MD, PhD
Phone +886-9-10513711
Email tonyyeh@ntuh.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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. Center 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.


Description:

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. Center 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. The 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600000
Est. completion date December 2040
Est. primary completion date July 2040
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - •Critically ill patients admitted to intensive care units Exclusion Criteria: - •Critically ill patients admitted to intensive care units

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Critical Care
Critical care in the intensive care units

Locations

Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Far Eastern Memorial Hospital New Taipei
Taiwan Taichung Veteran General Hospital Taichung
Taiwan Chi Mei Medical Center Tainan
Taiwan MacKay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University Hospital Taipei
Taiwan Chang Gung Medical Foundation Taoyuan
Taiwan National Taiwan University Hospital Yun-Lin Branch Yun-Lin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day mortality mortality status at 30 days after admission to intensive care unit 30 days
Secondary Length of stay in intensive care units Number of days in intensive care unite a median 2 to 7 days
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