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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163709




Registration number
NCT00163709
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
4/10/2006

Titles & IDs
Public title
BNP Testing in Patients With SOB on Presentation to ED
Scientific title
A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome
Secondary ID [1] 0 0
Heart Foundation Grant
Secondary ID [2] 0 0
116/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - BNP test

Treatment: Surgery: BNP test
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Allow more accurate diagnosis of heart failure.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Cause a change of management.
Timepoint [2] 0 0
Primary outcome [3] 0 0
Benefit some patients presenting with shortness fo breath more than others.
Timepoint [3] 0 0
Primary outcome [4] 0 0
Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
Timepoint [4] 0 0
Primary outcome [5] 0 0
Decrease hospital stay.
Timepoint [5] 0 0
Primary outcome [6] 0 0
Decrease hospital admission rate.
Timepoint [6] 0 0
Primary outcome [7] 0 0
Decrease the number of endotracheal intubations.
Timepoint [7] 0 0
Primary outcome [8] 0 0
Decrease 30-day mortality.
Timepoint [8] 0 0
Secondary outcome [1] 0 0
Improve long term outcomes in the Australian setting.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Improve cost effectiveness in the Australian setting.
Timepoint [2] 0 0

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hans Schneider, MBBS
Address 0 0
Head, Pathology Department
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163709