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

Study Locations

    • 台中市
      • Taichung City, 台中市, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

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

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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