Comparing the Diagnostic Sensitivity and Specificity of Pleural Fluid N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) and Other Biochemical Gradient Criteria in Distinguishing Heart Failure and Non-heart Failure Related Pleural Effusions (CENTRE Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients hospitalized for heart failure and pleural effusion

Pleural tapping indicated for pleural fluid analysis.

Aged 18 years old or above

Disqualifiers

History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space.

History of surgical decortication or pleurodesis in the ipsilateral pleural space.

Ipsilateral thoracic or cardiac surgery in the past 3 months.

Failure to obtain informed consent due to the patient's refusal or cognitive impairment.

Trial population

Patients who are admitted to the Department of Medicine \& Therapeutics, Prince of Wales Hospital (PWH) who fulfil the inclusion and exclusion criteria

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Heart Failure-Associated Pleural Effusion
Group B: Control group

Trial outcomes

Primary outcomes

1

Comparison of the diagnostic performance of PF NTproBNP level in the diagnosis of HF-associated pleural effusions with other conventional biochemical criteria

Pleural fluid NTproBNP will be measured in patients with pleural effusion of various aetiologies including malignancy, pleural infection, heart failure and other causes of volume overload. The sensitivity and specificity of an elevated pleural fluid NTproBNP level in successfully identifying a pleural effusion due to underlying heart failure will be measured and compared against existing classification criteria for pleural effusion such as Light's Criteria, pleural-serum protein gradient or albumin gradient.

Time frame
24 months

Secondary outcomes

1

To measure the PF NTproBNP level in patients with pleural effusion of various aetiologies

Time frame
24 months
2

Correlation of clinical factors that may affect the levels of pleural fluid NTproBNP such as echocardiographic features, presence of comorbidities, nutritional status, serum albumin level, levels of inflammatory markers and presence of infection

Clinical data of patients admitted to the hospital with pleural effusion will be measured and recorded. Statistical analysis will then be performed to evaluate for degree of correlation between the presence or severity of a clinical parameter, echocardiogram results e.g. severe valvular stenosis, or, e.g. presence of medical comorbidities or presence of concomitant infection, and the levels of NTproBNP identified in the patient's pleural fluid detected within same admission.

Time frame
24 months
3

To correlate the PF NTproBNP levels with the echocardiographic features and prognosis of patients with heart failure

Time frame
24 months

Other outcomes

Sponsors and contacts

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Chinese University of Hong Kong

Lead sponsor

Roche Diagnostics GmbH

Collaborator