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

Completed

• Conditions: Pneumonia

• Registration Number: NCT04396522
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Primary Completion: 2023-01-09
• Study Completion: 2023-02-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan