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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02441855
Other study ID # Pneumonia
Secondary ID
Status Completed
Phase N/A
First received May 8, 2015
Last updated June 2, 2015
Start date March 2015
Est. completion date May 2015

Study information

Verified date June 2015
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years of age

Exclusion Criteria:

- Patients with active pulmonary tuberculosis

- Hospital-acquired pneumonia

- Severely immunocompromised patients

- Patients undergoing chronic dialysis

- Patients sent for ambulatory treatment

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Education and Research Hospital Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the TAPSE value to discriminate patients with pneumonia the TAPSE (Tricuspid annular plane systolic excursion ) value to discriminate patients with pneumonia 1 month No
Secondary the BNP value to discriminate patients with pneumonia the BNP (B-type natriuretic peptide) value to discriminate patients with pneumonia 1 month No
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