Clinical trial NCT05797649: 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)
Official title: Comparing N-terminal-proB-type Natriuretic Peptide with Other Diagnostic Criteria in Discriminating Heart Failure-associated from Non-heart Failure-associated Pleural Effusions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion
Heart Failure
Malignant Neoplasm
Fluid Overload
Hypoalbuminemia
Renal Failure
Cirrhosis
Infections
Keywords: pleural fluid
heart failure
malignancy
cancer
echocardiography
infection
tuberculosis
respiratory medicine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2023-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to the Department of Medicine \& Therapeutics, Prince of Wales Hospital (PWH) who fulfil the inclusion and exclusion criteria

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the diagnostic performance of PF NTproBNP level in the diagnosis of HF-associated pleural effusions with other conventional biochemical criteria
timeFrame: 24 months
Secondary outcomes:
measure: To measure the PF NTproBNP level in patients with pleural effusion of various aetiologies
timeFrame: 24 months
measure: 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
timeFrame: 24 months
measure: To correlate the PF NTproBNP levels with the echocardiographic features and prognosis of patients with heart failure
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
References: