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

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ClinicalTrials.gov Identifier: NCT04396522
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Pneumonia Device: noninvasively Bio-electrical Impedance Analysis (BIA)

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, …)

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Serial Body Composition Change for Risk Prediction in Treating Patients With Severe Pneumonia
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia


Intervention Details:
  • Device: noninvasively Bio-electrical Impedance Analysis (BIA)
    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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396522


Contacts
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Contact: HUA Yeh +886 7 731 7123 ext 8775 yeahhunh@gmail.com

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung City, Taiwan, 83301
Contact: WEN-FENG Fang    +886 7 731 7123 ext 8775    yeahhunh@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: WEN-FENG Fang
Publications:
WF Fang CH, CY Lin, YT Fang, KT Huang, HC Kao, YH Wang, YT Chang, CC Wang, MC Lin. Immune Status and SeMo Score Predict Outcomes in Patients with Severe Sepsis. Am J Respir Crit Care Med. 2017;195:A1821.
KY Hung WF, CH Huang, YM Chen, CY Lin, YT Chang, KT Huang, YH Wang, CC Wang, MC Lin. Body mass index (BMI) can help predict immune status and short-term survival in patients with sepsis admitted to ICU. Respirology (Carlton, Vic.). 2018;23(s2):AP460.
WF Fang KH, YM Chen, YC Chong, YT Fang, KT Huang, YH Wang, H Yeh, YT Chang, CC Wang, MC Lin. Incremental Pulse Pressure Predicts Better Short-Term Outcomes in Patients with Sepsis Admitted to ICU. Am J Respir Crit Care Med. 2018;197:A6012.

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04396522    
Other Study ID Numbers: 201900375B0
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to disclose information about individual patients

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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
Keywords provided by Chang Gung Memorial Hospital:
pneumonia, sepsis, body composition
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases