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NCT04262440 Clinical Trial

The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients

ARDS Clinical Trial

Official title:
The Effect of Caloric Supplement in the Clinical Outcomes in Acute Lung Injury Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04262440
Other study ID # CF19068A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2019
Est. completion date December 31, 2022

Study information
Verified date February 2020
Source Taichung Veterans General Hospital
Contact CHEN-YU WANG, MHA
Phone 886-04-23592525
Email chestmen@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Taichung Veterans General Hospital Taichung City ???

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital mortality through study completion, an average of 1 year
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