- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262440
The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients
February 7, 2020 updated by: Wang, Chen-Yu, Taichung Veterans General Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CHEN-YU WANG, MHA
- Phone Number: 3167 886-04-23592525
- Email: chestmen@gmail.com
Study Locations
-
-
台中市
-
Taichung City, 台中市, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
-
Contact:
- CHEN-YU WANG, MHA
- Phone Number: 3167 886-04-23592525
- Email: chestmen@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS
Description
Inclusion Criteria:
Age older than 20 year old Respiratory failure with ventilator Fit the diagnostic criteria of ARDS (2012 Berlin Criteria)
Exclusion Criteria:
Expected ICU stay less than 72 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital mortality
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: CHEN-YU WANG, MHA, Department of Critical Care Medicine, Taichung Veterans General hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2019
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF19068A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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