Critical IllnessNCT04875260
Taiwan Center of Outcome and Resource Evaluation
An observational study of Critical Illness, run by National Taiwan University Hospital at 10 sites in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Critical Care
- How many people
- 600,000 participants
- Where
- 10 sitesTaiwan
- Study dates
- 1 Apr 2022to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted to intensive care units
Who may be able to join
- •Critically ill patients admitted to intensive care units
Who cannot join
- •Critically ill patients admitted to intensive care units
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Taiwan10 sites, 10 recruiting
- Not yet recruiting
National Taiwan University Hospital Yun-Lin Branch
Douliu
Chien-Hong Chou
- Not yet recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
Ming-Ju Tsai, MD, PhD
- Not yet recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Wei-Chun Huang, MD, PhD
- Not yet recruiting
Far Eastern Memorial Hospital
New Taipei City
Hou-Tai Chang, MD
- Recruiting
Taichung Veteran General Hospital
Taichung
Chieh-Liang Wu
- Recruiting
Chi Mei Medical Center
Tainan
Chin-Ming Chen
- Recruiting
MacKay Memorial Hospital
Taipei
Li-Kuo Kuo
- Recruiting
National Taiwan University Hospital
Taipei
Yu-Chang Yeh, MD, PhD, tonyyeh@ntuh.gov.tw
- Not yet recruiting
Taipei Medical University Hospital
Taipei
An-Yi Wang
- Not yet recruiting
Chang Gung Medical Foundation
Taoyuan
Kuan-Fu Chen, MD, PhD
About this study
Official title: Taiwan Center of Outcome and Resource Evaluation Adult Intensive Care Units Database
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.
Read the detailed 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.
- Conditions
- Critical Illness
- Being tested
- Critical Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical CareOther
Critical care in the intensive care units
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients received critical care in the intensive care units Receives: Other: Critical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
mortality status at 30 days after admission to intensive care unit
Measured: 30 days
Secondary outcomes (1)
Length of stay in intensive care units
Number of days in intensive care unite
Measured: a median 2 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Apr 2022
- Primary completionJul 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875260
- Sponsor's protocol ID
- 202006006RINA
- Status last verified
- Feb 2024
- First submitted
- 3 May 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Center of Outcome and Resource Evaluation Adult Intensive Care Units Database
- ClinicalTrials.gov ID
- NCT04875260
- Acronym / sponsor ID
- 202006006RINA
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Jul 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Other: Critical CarePatients received critical care in the intensive care units |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to intensive care units
Key inclusion criteria (1 listed)
- •Critically ill patients admitted to intensive care units
Key exclusion criteria (1 listed)
- •Critically ill patients admitted to intensive care units
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical CareCritical care in the intensive care units | Other | Critically ill patients |
Primary outcome
30-day mortality
Time frame: 30 days
mortality status at 30 days after admission to intensive care unit
1 secondary outcome
Length of stay in intensive care units
Time frame: a median 2 to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by National Taiwan University Hospital at 10 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chang Yeh, MD, PhD (+886-9-10513711, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.