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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396522
• Other study ID #: 201900375B0
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: February 21, 2023

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, …)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 21, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (42)

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Kao HC, Lai TY, Hung HL, Chen YM, Chou PA, Wang CC, Lin MC, Fang WF. Sequential oxygenation index and organ dysfunction assessment within the first 3 days of mechanical ventilation predict the outcome of adult patients with severe acute respiratory failure. ScientificWorldJournal. 2013;2013:413216. doi: 10.1155/2013/413216. Epub 2013 Feb 18. — View Citation

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* Note: There are 42 references in all — Click here to view all references

Outcome

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