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Patients with pleural effusion with an underlying aetiology of heart failure

Patients with pleural effusion with an underlying aetiology of fluid overload excluding heart failure

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

Christopher Chan, MBChB

Ken KP Chan, MBChB

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).

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.

Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis

Comparing N-terminal-proB-type Natriuretic Peptide With Other Diagnostic Criteria in Discriminating Heart Failure-associated From Non-heart Failure-associated Pleural Effusions

Given patient data and privacy concerns, clinical data involving individual patients will not be shared. Data summary tables may later be published along with the research manuscript, and may be shared upon receipt of a reasonable request.

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.

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.

Roche Diagnostics GmbH

Chinese University of Hong Kong

Honorary Clinical Tutor

Neoplasms

Skin and Connective Tissue Diseases

Lung Neoplasms

Breast Neoplasms

Empyema

Pleural Effusion, Malignant

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Suppuration

Inflammation

Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection

Carmmen Garcia

Luz Cuaboy

Jason Akulian, MD

Jason Akulian

Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

UNC Pleural Fluid Registry

University of North Carolina Pleural Fluid Registry

There is no plan to share IPD with other researchers.

Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry.

Study title	NCT ID	Conditions	Eligibility	Organization
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections	18 Years -	Chinese University of Hong Kong
Comparing N-terminal-proB-type Natriuretic Peptide With Other Criteria in Pleural Fluid Analysis	NCT05797649	Pleural Effusio... Heart Failure Malignant Neopl... Fluid Overload Hypoalbuminemia Renal Failure Cirrhosis Infections	18 Years -	Chinese University of Hong Kong
UNC Pleural Fluid Registry	NCT05620329	Lung Cancer Lung Infection Breast Cancer Malignant Pleur... Empyema	18 Years -	UNC Lineberger Comprehensive Cancer Center
UNC Pleural Fluid Registry	NCT05620329	Lung Cancer Lung Infection Breast Cancer Malignant Pleur... Empyema	18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for pleural fluid