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)

NCT ID: NCT05797649

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-11-30

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.

Conditions

Pleural Effusion; Heart Failure; Malignant Neoplasm; Fluid Overload; Hypoalbuminemia; Renal Failure; Cirrhosis; Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure-Associated Pleural Effusion

Patients with pleural effusion with an underlying aetiology of heart failure

No interventions assigned to this group

Control group

Patients with pleural effusion due to exudative, or non-fluid overload causes

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Christopher Chan

Honorary Clinical Tutor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Christopher Chan, MBChB

Role: CONTACT

christopherchan@cuhk.edu.hk

35053396

Ken KP Chan, MBChB

Role: CONTACT

chankapang@cuhk.edu.hk

35053396

Facility Contacts

Christopher Chan, MBChB

Role: primary

christopherchan@cuhk.edu.hk

85235052211 ext. 7607

Other Identifiers

NTProBNPPleuralEffusion1

Identifier Type: -

Identifier Source: org_study_id