ARDSNCT04262440
The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients
An observational study of ARDS, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The optimal amount caloric intake were still controversy in critically ill patients in literature. There were no significant outcome difference with different caloric intake in acute lung injury patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ARDS
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2019to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS
Who may be able to join
- Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS (2012 Berlin Criteria)
Who cannot join
- Expected ICU stay less than 72 hours
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 台中市, 40705
CHEN-YU WANG, MHA, 886-04-23592525 ext. 3167, chestmen@gmail.com
About this study
The optimal amount caloric intake were still controversy in critically ill patients in literature. There were no significant outcome difference with different caloric intake in acute lung injury patients. In order to identify the optimal amount caloric intake in acute lung injury patients, we conduct a prospectively observational study to see whether the caloric differences influence hospital mortality.
Read the detailed description
The is a prospectively observational study. The data including basic demographic data, daily PN/EN caloric intake, days of ICU stay, days of hospital stay, hospital mortality, days of ventilator use.. will be collected. Statistic analysis included chi-square, student t test, logistic regression and ROC curve will be applied to analyze the different characteristics between survived and died patients. Also we can figure out the optimal cut value of caloric intake with best outcome by ROC curve analysis. We plan enrolled 200 participants within study period.
- Conditions
- ARDS
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start11 Apr 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang, Chen-Yu, Taichung Veterans General Hospital
- Investigators
- CHEN-YU WANG, MHA, Principal investigator, Department of Critical Care Medicine, Taichung Veterans General hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262440
- Sponsor's protocol ID
- CF19068A
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients
- ClinicalTrials.gov ID
- NCT04262440
- Acronym / sponsor ID
- CF19068A
- Conditions
- ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Feb 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.
The optimal amount caloric intake were still controversy in critically ill patients in literature. There were no significant outcome difference with different caloric intake in acute lung injury patients. In order to identify the optimal amount caloric intake in acute lung injury patients, we conduct a prospectively observational study to see whether the caloric differences influence hospital mortality.
Detailed description
The is a prospectively observational study. The data including basic demographic data, daily PN/EN caloric intake, days of ICU stay, days of hospital stay, hospital mortality, days of ventilator use.. will be collected. Statistic analysis included chi-square, student t test, logistic regression and ROC curve will be applied to analyze the different characteristics between survived and died patients. Also we can figure out the optimal cut value of caloric intake with best outcome by ROC curve analysis. We plan enrolled 200 participants within study period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS
Key inclusion criteria (1 listed)
- Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS (2012 Berlin Criteria)
Key exclusion criteria (1 listed)
- Expected ICU stay less than 72 hours
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
Hospital mortality
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
CHEN-YU WANG, MHA principal investigator
Department of Critical Care Medicine, Taichung Veterans General hospital
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 ARDS, run by Taichung Veterans General 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 11 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHEN-YU WANG, MHA (886-04-23592525 ext. 3167, chestmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: through study completion, an average of 1 year). 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 11 Feb 2020.