- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Tilmelding
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Victoria
-
Melbourne, Victoria, Australien, 3004
- Rekruttering
- Alfred Hospital
-
Kontakt:
- Hans G Schneider, Associate Professor
- Telefonnummer: 613 9276 3118
- E-mail: schneiderh@alfred.org.au
-
Kontakt:
- Peter Cameron, Professor
- Telefonnummer: 613 9276 2000
- E-mail: peter.cameron@med.monash.edu.au
-
Ledende efterforsker:
- Hans G Schneider, MD FRCPA FRACP
-
Underforsker:
- Peter Cameron, MBBS,MD,FACEM
-
Underforsker:
- Henry Krum, MBBS,PhD,FRACP
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Allow more accurate diagnosis of heart failure.
|
Cause a change of management.
|
Benefit some patients presenting with shortness fo breath more than others.
|
Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
|
Decrease hospital stay.
|
Decrease hospital admission rate.
|
Decrease the number of endotracheal intubations.
|
Decrease 30-day mortality.
|
Sekundære resultatmål
Resultatmål |
---|
Improve long term outcomes in the Australian setting.
|
Improve cost effectiveness in the Australian setting.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hans Schneider, MBBS, Head, Pathology Department
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 116/05
- Heart Foundation Grant
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hjertesvigt, kongestiv
-
Region SkaneTilmelding efter invitationHjertesvigt New York Heart Association (NYHA) klasse II | Hjertesvigt New York Heart Association (NYHA) klasse IIISverige
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... og andre samarbejdspartnereIkke rekrutterer endnuHjertesvigt, systolisk | Hjertesvigt med reduceret udstødningsfraktion | Hjertesvigt New York Heart Association Klasse IV | Hjertesvigt New York Heart Association Klasse IIIPolen
-
University of WashingtonAmerican Heart AssociationAfsluttetHjertesvigt, Kongestiv | Mitokondriel ændring | Hjertesvigt New York Heart Association Klasse IVForenede Stater
-
Novartis PharmaceuticalsAfsluttetPatienter, der med succes afslutter den 12-måneders behandlingsperiode i kernestudiet (de Novo Heart-modtagere), som var interesserede i at blive behandlet med EC-MPS
-
University Hospital, GasthuisbergUkendtTransient Left Ventricular Ballooning SyndromeBelgien
-
NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForenede Stater
-
French Cardiology SocietyAfsluttet
Kliniske forsøg med BNP test
-
BiositeAfsluttet
-
Siemens Healthcare Diagnostics IncAfsluttet
-
Centre Hospitalier Universitaire de NiceAfsluttetPostoperative kardiovaskulære komplikationer
-
Philips Handheld DiagnosticsAfsluttet
-
Ben marzouk SofieneAfsluttetPlacenta Accreta | Placenta Previa | Normal graviditetTunesien
-
BiositeAfsluttetHjertefejlForenede Stater
-
University of Sao PauloUniversity of Sao Paulo General HospitalAfsluttetLevercirrhose | Hjertefejl | Ascites | CarcinomatoseBrasilien
-
Emergex Vaccines Holding Ltd.University of Lausanne Hospitals; Center for Primary Care and Public Health...Afsluttet
-
Centre Hospitalier Universitaire de TivoliRekruttering
-
Emergex Vaccines Holding Ltd.University of Lausanne Hospitals; Center for Primary Care and Public Health...AfsluttetCOVID-19 | Coronavirus | SARS-CoV-2 infektionSchweiz