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

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

NCT ID: NCT05797649

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

Conditions: Official terms:
Neoplasms
Pleural Effusion
Heart Failure
Hypoalbuminemia

Conditions: Keywords:
pleural fluid
heart failure
malignancy
cancer
echocardiography
infection
tuberculosis
respiratory medicine

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Prince of Wales Hospital

Address:
City: Hong Kong
Zip: 0000
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Christopher Chan, MBChB

Phone: 85235052211

Phone ext: 7607
Email: christopherchan@cuhk.edu.hk

Start date: July 1, 2023

Completion date: November 30, 2025

Lead sponsor:
Agency: Chinese University of Hong Kong
Agency class: Other

Collaborator:
Agency: Roche Diagnostics GmbH
Agency class: Industry

Source: Chinese University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05797649