Critical IllnessNCT04541849
Database for Predicting Clinical Outcomes of Critically Ill Patients
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 a 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 ICU database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Critical Care
- How many people
- 20,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 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
- patients aged less than 18 years
Trial locations and contacts
1 site in 1 country.
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
Official title: Predicting Clinical Outcomes of Critically Ill Patients in Intensive Care Units With De-identification Database
Australian and New Zealand Intensive Care Society (ANZICS) has built a 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 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. We retrospectively collected the data of patients discharged from the March 1, 2019 to June 30, 2022. Data of this database are permitted to study clinical problems and predict the clinical outcomes of these critically ill patients using statistical methods and machine learning techniques.
Read the detailed description
Data of this database are permitted to study the following clinical issues: including delirium, sepsis, acute kidney injury, acute respiratory distress syndrome, disseminated intravascular coagulation, multiple organ injuries, nutrition, survival status, number of days on ventilators, need for renal replacement therapy, length of stays in intensive care unit, length of stay in hospital, and other relevant clinical outcomes. It is also planned to analyze the clinical prognosis of special disease subgroups and establish a prediction model according to the type of patient's disease.
- 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 | Not described 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 (6)
Length of stay in intensive care unit
number of days in intensive care unite
Measured: Time of discharge from intensive care unit, a median of 2-7 days
Delirium
Events of delirium within 48 hours after ICU admission
Measured: 48 hours
Acute kidney Injury
Events of acute kidney injury within 48 hours
Time Frame:
Measured: 48 hours
Length of stay in intensive care unit
Number of days in intensive care unite
Measured: Time of discharge from hospital, more than 1 day
Disseminated intravascular coagulation
Events of disseminated intravascular coagulation within 48 hours after ICU admission
Measured: 48 hours
Acute respiratory distress syndrome
Events of acute respiratory distress syndrome within 48 hours after ICU admission
Measured: 48 hours
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 start10 Sep 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20,000 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
- NCT04541849
- Sponsor's protocol ID
- 202004016RINB
- Status last verified
- May 2024
- First submitted
- 30 Aug 2020
- Last updated
- 17 May 2024
- 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.
Publications
Yeh YC, Kuo YT, Kuo KC, Cheng YW, Liu DS, Lai F, Kuo LC, Lee TJ, Chan WS, Chiu CT, Tsai MT, Chao A, Chou NK, Yu CJ, Ku SC. Early prediction of mortality upon intensive care unit admission. BMC Med Inform Decis Mak. 2024 Dec 18;24(1):394. doi: 10.1186/s12911-024-02807-6.
PubMed 39696315
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Clinical Outcomes of Critically Ill Patients in Intensive Care Units With De-identification Database
- ClinicalTrials.gov ID
- NCT04541849
- Acronym / sponsor ID
- 202004016RINB
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (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 a 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 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. We retrospectively collected the data of patients discharged from the March 1, 2019 to June 30, 2022. Data of this database are permitted to study clinical problems and predict the clinical outcomes of these critically ill patients using statistical methods and machine learning techniques.
Detailed description
Data of this database are permitted to study the following clinical issues: including delirium, sepsis, acute kidney injury, acute respiratory distress syndrome, disseminated intravascular coagulation, multiple organ injuries, nutrition, survival status, number of days on ventilators, need for renal replacement therapy, length of stays in intensive care unit, length of stay in hospital, and other relevant clinical outcomes. It is also planned to analyze the clinical prognosis of special disease subgroups and establish a prediction model according to the type of patient's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Other: Critical Care |
Who may qualify
- Ages
- 18 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)
- patients aged less than 18 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 |
|---|---|---|
| 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
6 secondary outcomes
Length of stay in intensive care unit
Time frame: Time of discharge from intensive care unit, a median of 2-7 days
Delirium
Time frame: 48 hours
Acute kidney Injury
Time frame: 48 hours
Length of stay in intensive care unit
Time frame: Time of discharge from hospital, more than 1 day
Disseminated intravascular coagulation
Time frame: 48 hours
Acute respiratory distress syndrome
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 39696315Yeh YC, Kuo YT, Kuo KC, Cheng YW, Liu DS, Lai F, Kuo LC, Lee TJ, Chan WS, Chiu CT, Tsai MT, Chao A, Chou NK, Yu CJ, Ku SC. Early prediction of mortality upon intensive care unit admission. BMC Med Inform Decis Mak. 2024 Dec 18;24(1):394. doi: 10.1186/s12911-024-02807-6.
- 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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. This study is not recruiting at the moment.
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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT04541849, which also lists 1 linked publication.
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 17 May 2024.