- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00163709
BNP Testing in Patients With SOB on Presentation to ED
A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome
A trial to examine whether a new heart failure blood test can improve the outcome of patients presenting to the Emergency Department with shortness of breath.
We hypothesise that a BNP test performed in real-time in patients presenting to the Emergency Department with shortness of breath will help identify additional patients with CHF and consequently to change practice and allow more patients to recieve correct treatment earlier.
Studieoversikt
Detaljert beskrivelse
In recent years new tests to diagnose heart failure have become available. We are evaluating a new test called B-type natriuretic peptide(BNP)in patients presenting to the Emergency Department with shortness of breath. Patients are randomised into whether they will receive the new test or not. In the patient group where the test is positive, standardised approach that will optimise heart failure treatment will be introduced. We hypothesise that with this approach we will improve the clinical care of patients who present to the Emergency Department with shortness of breath. Measures of outcomes will be the accuracy of diagnosis 2 hours after presentation, 30 day mortality, hospital and ICU admission rates and quality of life at 30days.
We plan to investigate 600 consecutive patient presenting to the to the Emergency Department with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher. Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease, patients with cardiogenic shock and patients who have early transfer to another hospital(within 24 hrs) will be excluded.
Studietype
Registrering
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Victoria
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Melbourne, Victoria, Australia, 3004
- Rekruttering
- Alfred Hospital
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Ta kontakt med:
- Hans G Schneider, Associate Professor
- Telefonnummer: 613 9276 3118
- E-post: schneiderh@alfred.org.au
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Ta kontakt med:
- Peter Cameron, Professor
- Telefonnummer: 613 9276 2000
- E-post: peter.cameron@med.monash.edu.au
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Hovedetterforsker:
- Hans G Schneider, MD FRCPA FRACP
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Underetterforsker:
- Peter Cameron, MBBS,MD,FACEM
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Underetterforsker:
- Henry Krum, MBBS,PhD,FRACP
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
We plan to include all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher.
Exclusion Criteria:
Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Hva måler studien?
Primære resultatmål
Resultatmål |
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Allow more accurate diagnosis of heart failure.
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Cause a change of management.
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Benefit some patients presenting with shortness fo breath more than others.
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Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
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Decrease hospital stay.
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Decrease hospital admission rate.
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Decrease the number of endotracheal intubations.
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Decrease 30-day mortality.
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Sekundære resultatmål
Resultatmål |
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Improve long term outcomes in the Australian setting.
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Improve cost effectiveness in the Australian setting.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hans Schneider, MBBS, Head, Pathology Department
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lokuge A, Lam L, Cameron P, Krum H, de Villiers S, Bystrzycki A, Naughton MT, Eccleston D, Flannery G, Federman J, Schneider HG. B-type natriuretic peptide testing and the accuracy of heart failure diagnosis in the emergency department. Circ Heart Fail. 2010 Jan;3(1):104-10. doi: 10.1161/CIRCHEARTFAILURE.109.869438. Epub 2009 Nov 20.
- Schneider HG, Lam L, Lokuge A, Krum H, Naughton MT, De Villiers Smit P, Bystrzycki A, Eccleston D, Federman J, Flannery G, Cameron P. B-type natriuretic peptide testing, clinical outcomes, and health services use in emergency department patients with dyspnea: a randomized trial. Ann Intern Med. 2009 Mar 17;150(6):365-71. doi: 10.7326/0003-4819-150-6-200903170-00004.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 116/05
- Heart Foundation Grant
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