Acute Respiratory Distress SyndromeNCT03260348
Acute Respiratory Distress Syndrome in Taiwan
An observational study of Acute Respiratory Distress Syndrome, run by Chang Gung Memorial Hospital.
Trial summary
The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology and long-term outcomes of the patients will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 31 Jan 2023
- 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: All patients in medical intensive care unit during study period.
Who may be able to join
- Age >18 years
- Patients in medical intensive care unit in Sep., 2017 and Jan., 2018.
Who cannot join
- Age less than 18 years.
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
Kuo-Chin Kao contact
Tsang-Tang Hsieh contact
About this study
Official title: Epidemiology and Long-term Outcomes of Patients With Acute Respiratory Distress Syndrome in Taiwan
The study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology and long-term outcomes of the patients will be recorded.
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology
The incidence of ARDS in intensive care unit
Measured: two months
Mortality
The mortality rate of patients in hospital
Measured: 90 days
Long-term outcome
Performance status of live patients discharged.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuo-Chin Kao, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260348
- Sponsor's protocol ID
- 201701188B0
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Long-term Outcomes of Patients With Acute Respiratory Distress Syndrome in Taiwan
- ClinicalTrials.gov ID
- NCT03260348
- Acronym / sponsor ID
- 201701188B0
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 24 Aug 2017 (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 study enrolls ARDS patients in medical ICUs in 11 Hospitals in Taiwan. The epidemiology and long-term outcomes of the patients will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in medical intensive care unit during study period.
Key inclusion criteria (2 listed)
- Age >18 years
- Patients in medical intensive care unit in Sep., 2017 and Jan., 2018.
Key exclusion criteria (2 listed)
- Age less than 18 years.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology
Time frame: two months
The incidence of ARDS in intensive care unit
Mortality
Time frame: 90 days
The mortality rate of patients in hospital
Long-term outcome
Time frame: 5 years
Performance status of live patients discharged.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kuo-Chin Kao contact
Tsang-Tang Hsieh contact
Kuo-Chin Kao principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Chang Gung Memorial Hospital.
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 2 inclusion and 2 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 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Kuo-Chin Kao (kck0502@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology (time frame: two months). The study lists 3 primary outcomes in all. 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 24 Aug 2017.