Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000350628
Ethics application status
Approved
Date submitted
20/08/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
BNP in SOB
Scientific title
The impact of measuring brain type natriuretic peptide in patients with shortness of breath in the emergency department on management and subsequent patient mortality and morbidity.
Universal Trial Number (UTN)
Trial acronym
BNPSOB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive cardiac failure (CCF) 444 0
Condition category
Condition code
Cardiovascular 520 520 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To evaluate the role of B-type natriuretic peptide (BNP) in the management of patients presenting to the emergency department with the presenting symptom of shortness of breath (SOB). Patients randomised to the study group will have BNP levels tested. In the test group with a positive BNP result doctors will be encouraged to use a standardised approach to the optimum treatment of CCF. Blood is taken for BNP levels upon patient arrival and results will be available within one hour. The study duration is 18 months.
Intervention code [1] 215 0
Diagnosis / Prognosis
Comparator / control treatment
BNP levels are not tested in the control group.
Control group
Placebo

Outcomes
Primary outcome [1] 589 0
To evaluate the degree to which BNP testing changes the management of patients with SOB. The BNP level is available within one hour to the treating physician of patients in the study group. At this time, the treating physician will determine if this value altered clinical management of the patient.
Timepoint [1] 589 0
Secondary outcome [1] 1252 0
The impact of BNP on 30 day mortality
Timepoint [1] 1252 0
Secondary outcome [2] 1253 0
ICU admissions and quality of life.
Timepoint [2] 1253 0
At 30 days.

Eligibility
Key inclusion criteria
Presenting complaint of SOB, of triage categories 1-3.
Minimum age
40 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trauma patients, patients with renal failure or patients in cardiogenic shock.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random number generation. Whether a patient was randomised to the study group or the control group is not concealed from the study participants or the treating physicians.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel program was used to generate random numbers. There was no restrictions. Excel was further used on the random numbers to randomly allocate them to the study or control groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 579 0
Commercial sector/Industry
Name [1] 579 0
JANSEN SILAG
Country [1] 579 0
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Australia
Secondary sponsor category [1] 469 0
University
Name [1] 469 0
Monash University
Address [1] 469 0
Country [1] 469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1601 0
The Alfred Hospital Emergency and Trauma Centre
Ethics committee address [1] 1601 0
Ethics committee country [1] 1601 0
Australia
Date submitted for ethics approval [1] 1601 0
Approval date [1] 1601 0
Ethics approval number [1] 1601 0

Summary
Brief summary
To evaluate whether testing levels of BNP in patients presenting with shortness of breath has an impact on the management of these patients in the emergency department
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35988 0
Address 35988 0
Country 35988 0
Phone 35988 0
Fax 35988 0
Email 35988 0
Contact person for public queries
Name 9404 0
Professor Peter Cameron
Address 9404 0
Emergency and Trauma Centre
The Alfred Hospital
Commercial Road
Prahran VIC 3004
Country 9404 0
Australia
Phone 9404 0
+61 3 92762000
Fax 9404 0
+61 3 92766063
Email 9404 0
[email protected]
Contact person for scientific queries
Name 332 0
Professor Peter Cameron
Address 332 0
Emergency and Trauma Centre
The Alfred Hospital
Commercial Road
Prahran VIC 3004
Country 332 0
Australia
Phone 332 0
+61 3 92762000
Fax 332 0
+61 3 92766063
Email 332 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.