Sammenligning av N-terminal proB-type natriuretisk peptid med andre kriterier i pleuralvæskeanalyse
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).
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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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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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Å måle PF NTproBNP-nivået hos pasienter med pleural effusjon av ulike etiologier
Tidsramme: 24 måneder
|
24 måneder
|
|
|
For å korrelere PF NTproBNP-nivåene med ekkokardiografiske funksjoner og prognose for pasienter med hjertesvikt
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Hjertesykdommer
- Sykdommer i luftveiene
- Hematologiske sykdommer
- Gram-positive bakterielle infeksjoner
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Blodproteinforstyrrelser
- Actinomycetales infeksjoner
- Mycobacterium infeksjoner
- Pleurale sykdommer
- Hypoproteinemi
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hemic og lymfatiske sykdommer
- Neoplasmer
- Hjertefeil
- Fibrose
- Infeksjoner
- Nyreinsuffisiens
- Ødem
- Tuberkulose
- Pleuravæske
- Hypoalbuminemi
Andre studie-ID-numre
- NTProBNPPleuralEffusion1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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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