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

An observational study of Pneumonia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia
What is being tested?: noninvasively Bio-electrical Impedance Analysis (BIA)
Type of treatment: Medical device
How many people: 194 participants
Where: 1 siteTaiwan
Study dates: 1 May 2019to 21 Feb 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301

Other trials in Taiwan

About this study

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.

Read the detailed description

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, …)

Conditions: Pneumonia
Being tested: noninvasively Bio-electrical Impedance Analysis (BIA)
Keywords: pneumonia, sepsis, body composition
Medical subject headings: Pneumonia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201921 Feb 2023

First posted20 May 2020
Study start1 May 2019
Primary completion9 Jan 2023
Study completion21 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (42)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04396522
Sponsor's protocol ID: 201900375B0
Status last verified: Aug 2023
First submitted: 12 May 2020
Last updated: 6 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to disclose information about individual patients

Publications

Wunderink RG, Waterer GW. Community-acquired pneumonia. N Engl J Med. 2014 May 8;370(19):1863. doi: 10.1056/NEJMc1402692. No abstract available.
PubMed 24806181
Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.
PubMed 25830421
Fang WF, Yang KY, Wu CL, Yu CJ, Chen CW, Tu CY, Lin MC. Application and comparison of scoring indices to predict outcomes in patients with healthcare-associated pneumonia. Crit Care. 2011;15(1):R32. doi: 10.1186/cc9979. Epub 2011 Jan 19.
PubMed 21247444
Fang WF, Douglas IS, Chen YM, Lin CY, Kao HC, Fang YT, Huang CH, Chang YT, Huang KT, Wang YH, Wang CC, Lin MC. Development and validation of immune dysfunction score to predict 28-day mortality of sepsis patients. PLoS One. 2017 Oct 26;12(10):e0187088. doi: 10.1371/journal.pone.0187088. eCollection 2017.
PubMed 29073262
Tseng CC, Fang WF, Leung SY, Chen HC, Chang YC, Wang CC, Chang HC, Lin MC. Impact of serum biomarkers and clinical factors on intensive care unit mortality and 6-month outcome in relatively healthy patients with severe pneumonia and acute respiratory distress syndrome. Dis Markers. 2014;2014:804654. doi: 10.1155/2014/804654. Epub 2014 Mar 3.
PubMed 24723739
Phua J, Koh Y, Du B, Tang YQ, Divatia JV, Tan CC, Gomersall CD, Faruq MO, Shrestha BR, Gia Binh N, Arabi YM, Salahuddin N, Wahyuprajitno B, Tu ML, Wahab AY, Hameed AA, Nishimura M, Procyshyn M, Chan YH; MOSAICS Study Group. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011 Jun 13;342:d3245. doi: 10.1136/bmj.d3245.
PubMed 21669950
Manga G, Calin GA, Manuc M, Droc G, Tudor S. New Definitions of Sepsis and the Quest for Specific Biomarkers. Are the miRNAs the Answer? Chirurgia (Bucur). 2018 Jul-Aug;113(4):464-468. doi: 10.21614/chirurgia.113.4.464.
PubMed 30183576
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociacion Latinoamericana del Torax (ALAT). Eur Respir J. 2017 Sep 10;50(3):1700582. doi: 10.1183/13993003.00582-2017. Print 2017 Sep.
PubMed 28890434
Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
PubMed 27418577
Fang WF, Chen YM, Lin CY, Huang KT, Kao HC, Fang YT, Huang CH, Chang YT, Wang YH, Wang CC, Lin MC. Immune profiles and clinical outcomes between sepsis patients with or without active cancer requiring admission to intensive care units. PLoS One. 2017 Jul 10;12(7):e0179749. doi: 10.1371/journal.pone.0179749. eCollection 2017.
PubMed 28692671
Tseng CC, Fang WF, Huang KT, Chang PW, Tu ML, Shiang YP, Douglas IS, Lin MC. Risk factors for mortality in patients with nosocomial Stenotrophomonas maltophilia pneumonia. Infect Control Hosp Epidemiol. 2009 Dec;30(12):1193-202. doi: 10.1086/648455.
PubMed 19852664
Chen YM, Fang WF, Kao HC, Chen HC, Tsai YC, Shen LS, Li CL, Chang HC, Huang KT, Lin MC, Wang CC, Chao TY. Influencing factors of successful eradication of multidrug-resistant Acinetobacter baumannii in the respiratory tract with aerosolized colistin. Biomed J. 2014 Sep-Oct;37(5):314-20. doi: 10.4103/2319-4170.132879.
PubMed 25179700
Tseng CC, Liu SF, Wang CC, Tu ML, Chung YH, Lin MC, Fang WF. Impact of clinical severity index, infective pathogens, and initial empiric antibiotic use on hospital mortality in patients with ventilator-associated pneumonia. Am J Infect Control. 2012 Sep;40(7):648-52. doi: 10.1016/j.ajic.2011.08.017. Epub 2012 Jan 13.
PubMed 22243991
Huang KT, Tseng CC, Fang WF, Lin MC. An early predictor of the outcome of patients with ventilator-associated pneumonia. Chang Gung Med J. 2010 May-Jun;33(3):274-82.
PubMed 20584505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Serial Body Composition Change for Risk Prediction in Treating Patients With Severe Pneumonia
ClinicalTrials.gov ID: NCT04396522
Acronym / sponsor ID: 201900375B0
Conditions: Pneumonia
Keywords: pneumonia, sepsis, body composition
Study type: Observational
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 1 May 2019 (actual)
Primary completion: 9 Jan 2023 (actual)
Study completion: 21 Feb 2023 (actual)
First posted: 20 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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, …)

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with pneumonia admitted to the thoracic ward or medical intensive care unit of the Kaohsiung Chang Gung Memorial Hospital

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	–

Primary outcome

ICU Days
Time frame: During hospitalization， "through study completion, an average of 1 year"
length of stay in ICU
Ventilation days
Time frame: up to 24 weeks
days of mechanical ventilation
sepsis free days
Time frame: up to 24 weeks
the cure day of sepsis
mortality
Time frame: During hospitalization， "through study completion, an average of 1 year"
death rate
Change in Total Body Water
Time frame: Change from Baseline Total Body Water at day 8
Change in Total Body Water
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 in Soft Lean Mass
Time frame: Change from Baseline Soft Lean Mass at day 8
Change in Soft Lean Mass
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Background: PubMed 24806181Wunderink RG, Waterer GW. Community-acquired pneumonia. N Engl J Med. 2014 May 8;370(19):1863. doi: 10.1056/NEJMc1402692. No abstract available.
Background: PubMed 25830421Postma DF, van Werkhoven CH, van Elden LJ, Thijsen SF, Hoepelman AI, Kluytmans JA, Boersma WG, Compaijen CJ, van der Wall E, Prins JM, Oosterheert JJ, Bonten MJ; CAP-START Study Group. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med. 2015 Apr 2;372(14):1312-23. doi: 10.1056/NEJMoa1406330.
Background: PubMed 21247444Fang WF, Yang KY, Wu CL, Yu CJ, Chen CW, Tu CY, Lin MC. Application and comparison of scoring indices to predict outcomes in patients with healthcare-associated pneumonia. Crit Care. 2011;15(1):R32. doi: 10.1186/cc9979. Epub 2011 Jan 19.
Background: PubMed 29073262Fang WF, Douglas IS, Chen YM, Lin CY, Kao HC, Fang YT, Huang CH, Chang YT, Huang KT, Wang YH, Wang CC, Lin MC. Development and validation of immune dysfunction score to predict 28-day mortality of sepsis patients. PLoS One. 2017 Oct 26;12(10):e0187088. doi: 10.1371/journal.pone.0187088. eCollection 2017.
Background: PubMed 24723739Tseng CC, Fang WF, Leung SY, Chen HC, Chang YC, Wang CC, Chang HC, Lin MC. Impact of serum biomarkers and clinical factors on intensive care unit mortality and 6-month outcome in relatively healthy patients with severe pneumonia and acute respiratory distress syndrome. Dis Markers. 2014;2014:804654. doi: 10.1155/2014/804654. Epub 2014 Mar 3.
Background: PubMed 21669950Phua J, Koh Y, Du B, Tang YQ, Divatia JV, Tan CC, Gomersall CD, Faruq MO, Shrestha BR, Gia Binh N, Arabi YM, Salahuddin N, Wahyuprajitno B, Tu ML, Wahab AY, Hameed AA, Nishimura M, Procyshyn M, Chan YH; MOSAICS Study Group. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011 Jun 13;342:d3245. doi: 10.1136/bmj.d3245.
Background: PubMed 30183576Manga G, Calin GA, Manuc M, Droc G, Tudor S. New Definitions of Sepsis and the Quest for Specific Biomarkers. Are the miRNAs the Answer? Chirurgia (Bucur). 2018 Jul-Aug;113(4):464-468. doi: 10.21614/chirurgia.113.4.464.
Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Background: PubMed 28890434Torres A, Niederman MS, Chastre J, Ewig S, Fernandez-Vandellos P, Hanberger H, Kollef M, Li Bassi G, Luna CM, Martin-Loeches I, Paiva JA, Read RC, Rigau D, Timsit JF, Welte T, Wunderink R. International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociacion Latinoamericana del Torax (ALAT). Eur Respir J. 2017 Sep 10;50(3):1700582. doi: 10.1183/13993003.00582-2017. Print 2017 Sep.
Background: PubMed 27418577Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14.
Background: PubMed 28692671Fang WF, Chen YM, Lin CY, Huang KT, Kao HC, Fang YT, Huang CH, Chang YT, Wang YH, Wang CC, Lin MC. Immune profiles and clinical outcomes between sepsis patients with or without active cancer requiring admission to intensive care units. PLoS One. 2017 Jul 10;12(7):e0179749. doi: 10.1371/journal.pone.0179749. eCollection 2017.
Background: PubMed 19852664Tseng CC, Fang WF, Huang KT, Chang PW, Tu ML, Shiang YP, Douglas IS, Lin MC. Risk factors for mortality in patients with nosocomial Stenotrophomonas maltophilia pneumonia. Infect Control Hosp Epidemiol. 2009 Dec;30(12):1193-202. doi: 10.1086/648455.
Individual participant dataSharing planned: No. There is no plan to disclose information about individual patients

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

WEN-FENG Fang principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICU Days (time frame: During hospitalization， "through study completion, an average of 1 year"). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396522, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.