Community-acquired PneumoniaNCT02441855
Potential Role for Echocardiography in Adult Patients With Community-Acquired Pneumonia
An observational study of Community-acquired Pneumonia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the leading cause of death. Prognostic scores have been developed to estimate the risk of adverse outcome. Several serum biomarkers have been also investigated in patients with CAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- echocardiography
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to May 2015
- 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: Pneumonia group is defined as patients with community acquired pneumonia diagnosis hospitalised through emergency department. The control group will be consisted of consecutive sex- and age-matched patients admitted to the emergency department.
Who may be able to join
- ≥ 18 years of age
Who cannot join
- Patients with active pulmonary tuberculosis
- Hospital-acquired pneumonia
- Severely immunocompromised patients
- Patients undergoing chronic dialysis
- Patients sent for ambulatory treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University Education and Research Hospital
Muğla
About this study
Official title: Is There a Potential Role for Echocardiography in Adult Patients With Community-Acquired Pneumonia Who Require Hospitalization ? A Pilot Study
Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the leading cause of death. Prognostic scores have been developed to estimate the risk of adverse outcome. Several serum biomarkers have been also investigated in patients with CAP. A growing number of echocardiographic markers have been evaluated as possible predictors of prognosis in patients with pulmonary and infectious diseases such as sepsis, septic shock, human immunodeficiency virus infection, pulmonary tuberculosis, and chronic obstructive pulmonary disease. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible diagnostic tool to evaluate cardiac function and structures, the investigators aimed to investigate left and right ventricular functions and aortic elastic properties in CAP patients. Furthermore, the investigators also aimed to observe relationships between echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with CAP.
Read the detailed description
Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the leading cause of death. Prognostic scores, like the CURB-65 (confusion, urea, respiratory rate, arterial blood pressure and age) score and the pneumonia severity index (PSI) have been developed and validated to estimate the risk of adverse outcome and to register a patient with CAP for hospital admission. Serum biomarkers have been also investigated in patients with CAP like Procalcitonin and C-reactive protein. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) has been shown to be associated with adverse prognosis in several cardiac conditions and critically ill patients. NT-proBNP is also shown to be important predictor in the emergency department and in hospitalized patients with CAP. A growing number of echocardiographic markers have been evaluated as possible predictors of prognosis in patients with pulmonary and infectious diseases such as sepsis, pulmonary tuberculosis, and chronic obstructive pulmonary disease. Although effects of pneumonia on cardiac structures is theoretically possible due to increased systemic inflammatory activity, prothrombotic conditions, biomechanical stress on coronary arteries, variations in coronary arterial tone, and altered myocardial metabolic balance during infections, the role of transthoracic echocardiography has never been evaluated in patients with CAP. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible diagnostic tool to evaluate cardiac function and structures, the investigators aimed to investigate left and right ventricular functions and aortic elastic properties in CAP patients. Furthermore, the investigators also aimed to observe relationships between echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with CAP.
- Conditions
- Community-acquired Pneumonia
- Being tested
- echocardiography
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDevice
echocardiography: Left and right ventricular functions and aortic elastic properties.
| Study group | Role | What they receive |
|---|---|---|
| pneumonia | patients with community-acquired pneumonia Receives: Device: echocardiography | |
| control | patients admitted to emergency department with shortness of breath Receives: Device: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the TAPSE value to discriminate patients with pneumonia
the TAPSE (Tricuspid annular plane systolic excursion ) value to discriminate patients with pneumonia
Measured: 1 month
Secondary outcomes (1)
the BNP value to discriminate patients with pneumonia
the BNP (B-type natriuretic peptide) value to discriminate patients with pneumonia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozcan Basaran, Muğla Sıtkı Koçman University
- Investigators
- Murat Biteker, Assoc. Prof., Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441855
- Sponsor's protocol ID
- Pneumonia
- Status last verified
- Jun 2015
- First submitted
- 8 May 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Biteker FS, Biteker M, Basaran O, Dogan V, Ozlek B, Yildirim B, Ozlek E, Celik O. A small pericardial effusion is a marker of complicated hospitalization in patients with community-acquired pneumonia. J Crit Care. 2018 Apr;44:294-299. doi: 10.1016/j.jcrc.2017.11.030. Epub 2017 Nov 23.
PubMed 29247912Biteker FS, Basaran O, Dogan V, Caylak SD, Yildirim B, Sozen H. Prognostic value of transthoracic echocardiography and biomarkers of cardiac dysfunction in community-acquired pneumonia. Clin Microbiol Infect. 2016 Dec;22(12):1006.e1-1006.e6. doi: 10.1016/j.cmi.2016.08.016. Epub 2016 Sep 3.
PubMed 27596535
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Potential Role for Echocardiography in Adult Patients With Community-Acquired Pneumonia Who Require Hospitalization ? A Pilot Study
- ClinicalTrials.gov ID
- NCT02441855
- Acronym / sponsor ID
- Pneumonia
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the leading cause of death. Prognostic scores have been developed to estimate the risk of adverse outcome. Several serum biomarkers have been also investigated in patients with CAP. A growing number of echocardiographic markers have been evaluated as possible predictors of prognosis in patients with pulmonary and infectious diseases such as sepsis, septic shock, human immunodeficiency virus infection, pulmonary tuberculosis, and chronic obstructive pulmonary disease. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible diagnostic tool to evaluate cardiac function and structures, the investigators aimed to investigate left and right ventricular functions and aortic elastic properties in CAP patients. Furthermore, the investigators also aimed to observe relationships between echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with CAP.
Detailed description
Despite the efficacy of modern treatment, community-acquired pneumonia (CAP) is the the leading cause of death. Prognostic scores, like the CURB-65 (confusion, urea, respiratory rate, arterial blood pressure and age) score and the pneumonia severity index (PSI) have been developed and validated to estimate the risk of adverse outcome and to register a patient with CAP for hospital admission. Serum biomarkers have been also investigated in patients with CAP like Procalcitonin and C-reactive protein. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) has been shown to be associated with adverse prognosis in several cardiac conditions and critically ill patients. NT-proBNP is also shown to be important predictor in the emergency department and in hospitalized patients with CAP. A growing number of echocardiographic markers have been evaluated as possible predictors of prognosis in patients with pulmonary and infectious diseases such as sepsis, pulmonary tuberculosis, and chronic obstructive pulmonary disease. Although effects of pneumonia on cardiac structures is theoretically possible due to increased systemic inflammatory activity, prothrombotic conditions, biomechanical stress on coronary arteries, variations in coronary arterial tone, and altered myocardial metabolic balance during infections, the role of transthoracic echocardiography has never been evaluated in patients with CAP. As echocardiography is a non-invasive, reliable, cost-effective, and reproducible diagnostic tool to evaluate cardiac function and structures, the investigators aimed to investigate left and right ventricular functions and aortic elastic properties in CAP patients. Furthermore, the investigators also aimed to observe relationships between echocardiographic findings and inflammatory and cardiac serum biomarkers in patients with CAP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pneumonia | – | Device: echocardiographypatients with community-acquired pneumonia |
| control | – | Device: echocardiographypatients admitted to emergency department with shortness of breath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pneumonia group is defined as patients with community acquired pneumonia diagnosis hospitalised through emergency department. The control group will be consisted of consecutive sex- and age-matched patients admitted to the emergency department.
Key inclusion criteria (1 listed)
- ≥ 18 years of age
Key exclusion criteria (5 listed)
- Patients with active pulmonary tuberculosis
- Hospital-acquired pneumonia
- Severely immunocompromised patients
- Patients undergoing chronic dialysis
- Patients sent for ambulatory treatment
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 |
|---|---|---|
| echocardiographyechocardiography: Left and right ventricular functions and aortic elastic properties. | Device | control, pneumonia |
Primary outcome
the TAPSE value to discriminate patients with pneumonia
Time frame: 1 month
the TAPSE (Tricuspid annular plane systolic excursion ) value to discriminate patients with pneumonia
1 secondary outcome
the BNP value to discriminate patients with pneumonia
Time frame: 1 month
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 4 Jun 2015.
- Derived from this study: PubMed 29247912Biteker FS, Biteker M, Basaran O, Dogan V, Ozlek B, Yildirim B, Ozlek E, Celik O. A small pericardial effusion is a marker of complicated hospitalization in patients with community-acquired pneumonia. J Crit Care. 2018 Apr;44:294-299. doi: 10.1016/j.jcrc.2017.11.030. Epub 2017 Nov 23.
- Derived from this study: PubMed 27596535Biteker FS, Basaran O, Dogan V, Caylak SD, Yildirim B, Sozen H. Prognostic value of transthoracic echocardiography and biomarkers of cardiac dysfunction in community-acquired pneumonia. Clin Microbiol Infect. 2016 Dec;22(12):1006.e1-1006.e6. doi: 10.1016/j.cmi.2016.08.016. Epub 2016 Sep 3.
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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.
Murat Biteker, Assoc. Prof. study director
Muğla Sıtkı Koçman University
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 Community-acquired Pneumonia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 5 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 4 Jun 2015. 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 Turkey (Türkiye). 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?
the TAPSE value to discriminate patients with pneumonia (time frame: 1 month). 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 NCT02441855, which also lists 2 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 4 Jun 2015.