Critical IllnessNCT04541862
Adult Intensive Care Units Database of National Taiwan University Hospital
An observational study of Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. 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?
- Intensive care
- How many people
- 200,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Oct 2019to Dec 2043
- How long will I take part?
- 6 Months
- 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
- 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
- Patients aged less than 20 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Chang Yeh, MD, PhD, +886-910513711, tonyyeh@ntuh.gov.tw
About this study
Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU .
This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043.
The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.
- Conditions
- Critical Illness
- Being tested
- Intensive 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.
Intensive careOther
intensive care for critically ill patients in the intensive care units
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Not described Receives: Other: Intensive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Survival status at 30 days after ICU admission
Measured: 30 days
Secondary outcomes (1)
Length of stay in intensive care unit
Length of stay (days) in intensive care unit
Measured: Time to discharge from intensive care unit, a median of 2-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start23 Oct 2019
- Primary completionJun 2043 (estimated)
- Study completionDec 2043 (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
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 6 Months
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
- NCT04541862
- Sponsor's protocol ID
- 201901010RIND
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available according to the regulation of Research Ethic Committee of National Taiwan University Hospital.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Intensive Care Units Database of National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT04541862
- Acronym / sponsor ID
- 201901010RIND
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Jun 2043 (estimated)
- Study completion
- Dec 2043 (estimated)
- First posted
- 9 Sep 2020 (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.
Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU .
This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043.
The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Other: Intensive care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- 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)
- Patients aged less than 20 years
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 |
|---|---|---|
| Intensive careintensive care for critically ill patients in the intensive care units | Other | Critically ill patients |
Primary outcome
30-day mortality
Time frame: 30 days
Survival status at 30 days after ICU admission
1 secondary outcome
Length of stay in intensive care unit
Time frame: Time to discharge from intensive care unit, a median of 2-7 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 9 Sep 2020.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available according to the regulation of Research Ethic Committee of National Taiwan University Hospital.
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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.
1 site 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 1 site 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 9 Sep 2020.