Current partner codePEPTIDESDE
NCT05797649·Not applicable·OBSERVATIONAL

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)

Status

Recruiting

Phase

Not applicable

Enrollment

120

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Full detailed description

Objective: 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). Hypothesis to be tested: The PF NTproBNP levels are superior to existing methods including Light's criteria, serum/pleural fluid (S/PF) protein gradient, and albumin gradient, in identifying transudates and distinguishing between HF- and non-HF-associated PE. Design and subjects: A prospective case-control study involving patients with PE requiring thoracentesis, caused by hypervolaemia due to HF, diseases other than HF, and patients with pleural effusion without hypervolaemia. Patient characteristics, PF results and effusion aetiology will be analysed. Patient outcomes will be followed up to 3 months to confirm the aetiology of PE. Clinical management of patients will not be affected. Study instruments: PF of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (LDH) levels and NTproBNP. The diagnosis of HF will be based on clinical features, serum NTproBNP and echocardiogram. Main outcome measures: The performance of PF NTproBNP level in identifying HF-associated PE. Data analysis: The PF NTproBNP level will be compared between effusions of different aetiologies. The optimal pleural fluid NTproBNP level with largest area under the receiver operating characteristic curve in identifying HF-associated PE will be determined. Performance of PF NTproBNP level in identifying HF-associated PE, and other biochemical criteria in identifying transudates will be compared. Echocardiographic findings will be correlated with the PF NTproBNP levels. Expected results: The diagnostic performance of PF NTproBNP will be significantly better in identifying HF-associated effusion than other biochemical criteria.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Apr 4, 2023

  2. Study start

    Jul 1, 2023

  3. Primary completion

    Nov 30, 2025

  4. Study completion

    Nov 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Nov 13, 2024

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 24 months

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.

Secondary outcomes

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

Time frame · 24 months

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

Time frame · 24 months

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.

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

Time frame · 24 months

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Patients hospitalized for heart failure and pleural effusion * Pleural tapping indicated for pleural fluid analysis. * Aged 18 years old or above Exclusion Criteria: * 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.

Study locations

1 registered sites.

Hong Kong. Showing up to 24 locations stored in the fast local snapshot.

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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