Sammenligning af N-terminal-proB-type natriuretisk peptid med andre kriterier i pleuravæskeanalyse
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).
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
New Territories
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Hong Kong, New Territories, Hong Kong, 0000
- Prince of Wales Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients who are admitted to the Department of Medicine & Therapeutics, Prince of Wales Hospital (PWH) who fulfil the inclusion and exclusion criteria
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Heart Failure-Associated Pleural Effusion
Patients with pleural effusion with an underlying aetiology of heart failure |
|
Control group
Patients with pleural effusion due to exudative, or non-fluid overload causes |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of the diagnostic performance of PF NTproBNP level in the diagnosis of HF-associated pleural effusions with other conventional biochemical criteria
Tidsramme: 24 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
At måle PF NTproBNP-niveauet hos patienter med pleural effusion af forskellige ætiologier
Tidsramme: 24 måneder
|
24 måneder
|
|
|
At korrelere PF NTproBNP-niveauerne med de ekkokardiografiske funktioner og prognose for patienter med hjertesvigt
Tidsramme: 24 måneder
|
24 måneder
|
|
|
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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Hjertesygdomme
- Luftvejssygdomme
- Hæmatologiske sygdomme
- Gram-positive bakterielle infektioner
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Blodproteinforstyrrelser
- Actinomycetales infektioner
- Mycobacterium infektioner
- Pleurale sygdomme
- Hypoproteinæmi
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Neoplasmer
- Hjertefejl
- Fibrose
- Infektioner
- Nyreinsufficiens
- Ødem
- Tuberkulose
- Pleural effusion
- Hypoalbuminæmi
Andre undersøgelses-id-numre
- NTProBNPPleuralEffusion1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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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