Jämföra N-terminal-proB-typ natriuretisk peptid med andra kriterier i pleuravätskeanalys
Comparing N-terminal-proB-type Natriuretic Peptide With Other Diagnostic Criteria in Discriminating Heart Failure-associated From Non-heart Failure-associated Pleural Effusions
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).
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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New Territories
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Hong Kong, New Territories, Hong Kong, 0000
- Prince of Wales Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients who are admitted to the Department of Medicine & Therapeutics, Prince of Wales Hospital (PWH) who fulfil the inclusion and exclusion criteria
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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Heart Failure-Associated Pleural Effusion
Patients with pleural effusion with an underlying aetiology of heart failure |
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Control group
Patients with pleural effusion due to exudative, or non-fluid overload causes |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparison of the diagnostic performance of PF NTproBNP level in the diagnosis of HF-associated pleural effusions with other conventional biochemical criteria
Tidsram: 24 months
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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. |
24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Att mäta PF NTproBNP-nivån hos patienter med pleurautgjutning av olika etiologier
Tidsram: 24 månader
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24 månader
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Att korrelera PF NTproBNP-nivåerna med ekokardiografiska egenskaper och prognos för patienter med hjärtsvikt
Tidsram: 24 månader
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24 månader
|
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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
Tidsram: 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. |
24 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Hjärtsjukdom
- Luftvägssjukdomar
- Hematologiska sjukdomar
- Gram-positiva bakteriella infektioner
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Blodproteinstörningar
- Actinomycetales infektioner
- Mycobacterium infektioner
- Pleurala sjukdomar
- Hypoproteinemi
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Hemiska och lymfsjukdomar
- Neoplasmer
- Hjärtsvikt
- Fibros
- Infektioner
- Njurinsufficiens
- Ödem
- Tuberkulos
- Pleural effusion
- Hypoalbuminemi
Andra studie-ID-nummer
- NTProBNPPleuralEffusion1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
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