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OpenTrials
Completed

NCT Number: NCT04396522

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

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.

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Key information

Conditions

Pneumonia Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

Specific aims:

  • 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,..)
  • 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?
  • 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, …)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

noninvasively Bio-electrical Impedance Analysis (BIA)

Device

By means of noninvasively Bio-electrical Impedance Analysis (BIA) to measure body composition, which divides body weight into different components such as lean body mass and fat mass.

Primary outcomes

  1. ICU Days

    Time frame: During hospitalization， "through study completion, an average of 1 year"

    length of stay in ICU

  2. Ventilation days

    Time frame: up to 24 weeks

    days of mechanical ventilation

  3. sepsis free days

    Time frame: up to 24 weeks

    the cure day of sepsis

  4. mortality

    Time frame: During hospitalization， "through study completion, an average of 1 year"

    death rate

  5. Change in Total Body Water

    Time frame: Change from Baseline Total Body Water at day 8

    Change in Total Body Water

  6. Change in Percentage of Body Fat

    Time frame: Change from Baseline Percentage of Body Fat at day 8

    Change in Percentage of Body Fat

  7. Change in Soft Lean Mass

    Time frame: Change from Baseline Soft Lean Mass at day 8

    Change in Soft Lean Mass

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 20, 2020
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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