Application of Serial Body Composition Change for Risk Prediction in Treating Patients With Severe Pneumonia

August 31, 2023 updated by: Chang Gung Memorial Hospital
We hypothesize that serial changes of body composition in patients with pneumonia can help clinician to monitor prognosis. It was associated with underlying immune response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific aims:

  1. Can serial body composition data be useful for predicting outcomes of patients with pneumonia? (developing sepsis, organ failure, admission to ICU, length of ICU, survival, length of stay in hospital, prolonged mechanical ventilation,..)
  2. Can serial body composition data be integrated into both immune status alternatives (e.g., white blood cell (WBC) count, segment/monocyte ratio, pulse pressure) in such critical illness and monitoring responses (SOFA score, labs) for severe pneumonia patients?
  3. Can serial body composition data reflect clinical variables in patients with pneumonia, and even altered by nutrition intake? (e.g., compare association between nutrition intake amount and groups stratified by body composition, blood pressure, nutritional intake, …)

Study Type

Observational

Enrollment (Actual)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with pneumonia admitted to the thoracic ward or medical intensive care unit of the Kaohsiung Chang Gung Memorial Hospital

Description

Inclusion Criteria:

Adult patients with pneumonia admitted to the thoracic ward or medical intensive care unit of Kaohsiung Chang Gung Memorial Hospital

Exclusion Criteria:

-

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
Measure Description
Time Frame
ICU Days
Time Frame: During hospitalization， "through study completion, an average of 1 year"
length of stay in ICU
During hospitalization， "through study completion, an average of 1 year"
Ventilation days
Time Frame: up to 24 weeks
days of mechanical ventilation
up to 24 weeks
sepsis free days
Time Frame: up to 24 weeks
the cure day of sepsis
up to 24 weeks
mortality
Time Frame: During hospitalization， "through study completion, an average of 1 year"
death rate
During hospitalization， "through study completion, an average of 1 year"
Change in Total Body Water
Time Frame: Change from Baseline Total Body Water at day 8
Change in Total Body Water
Change from Baseline Total Body Water at day 8
Change in Percentage of Body Fat
Time Frame: Change from Baseline Percentage of Body Fat at day 8
Change in Percentage of Body Fat
Change from Baseline Percentage of Body Fat at day 8
Change in Soft Lean Mass
Time Frame: Change from Baseline Soft Lean Mass at day 8
Change in Soft Lean Mass
Change from Baseline Soft Lean Mass at day 8
Change in segment/monocyte ratio
Time Frame: Change from Baseline Segment count to monocyte count ratio at day 8
Change in Segment count to monocyte count ratio
Change from Baseline Segment count to monocyte count ratio at day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: WEN-FENG Fang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2019

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900375B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to disclose information about individual patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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