NCT02441855

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

May 8, 2015

Last Update Submit

June 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • the TAPSE value to discriminate patients with pneumonia

    the TAPSE (Tricuspid annular plane systolic excursion ) value to discriminate patients with pneumonia

    1 month

Secondary Outcomes (1)

  • the BNP value to discriminate patients with pneumonia

    1 month

Study Arms (2)

pneumonia

patients with community-acquired pneumonia

Device: echocardiography

control

patients admitted to emergency department with shortness of breath

Device: echocardiography

Interventions

echocardiography: Left and right ventricular functions and aortic elastic properties.

controlpneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ≥ 18 years of age

You may not qualify if:

  • Patients with active pulmonary tuberculosis
  • Hospital-acquired pneumonia
  • Severely immunocompromised patients
  • Patients undergoing chronic dialysis
  • Patients sent for ambulatory treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University Education and Research Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • Biteker 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.

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Murat Biteker, Assoc. Prof.

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 12, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations