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BNP Testing in Patients With SOB on Presentation to ED

Primary Purpose

Heart Failure, Congestive

Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BNP test
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure, Congestive focused on measuring Atrial natriuretic factor., Biochemistry., Cardiac failure., Randomised trials., Hormones., Systolic heart failure., Diastolic heart failure., Ischaemic cardiomyopathy., Ventricular hypertrophy., AMI

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alfred HospitalRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improve long term outcomes in the Australian setting.
Improve cost effectiveness in the Australian setting.

Full Information

First Posted
September 11, 2005
Last Updated
October 3, 2006
Sponsor
Bayside Health
Collaborators
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT00163709
Brief Title
BNP Testing in Patients With SOB on Presentation to ED
Official Title
A Randomised Trial of BNP Testing in Patients With Shortness of Breath in the Emergency Department to Improve Patient Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health
Collaborators
The Alfred

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Atrial natriuretic factor., Biochemistry., Cardiac failure., Randomised trials., Hormones., Systolic heart failure., Diastolic heart failure., Ischaemic cardiomyopathy., Ventricular hypertrophy., AMI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
BNP test
Primary Outcome Measure Information:
Title
Allow more accurate diagnosis of heart failure.
Title
Cause a change of management.
Title
Benefit some patients presenting with shortness fo breath more than others.
Title
Increse the use of early Continuous Positive Airway Pressure (CPAP) ventilation, nitrates, loop diuretics and ACE inhibitors.
Title
Decrease hospital stay.
Title
Decrease hospital admission rate.
Title
Decrease the number of endotracheal intubations.
Title
Decrease 30-day mortality.
Secondary Outcome Measure Information:
Title
Improve long term outcomes in the Australian setting.
Title
Improve cost effectiveness in the Australian setting.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Schneider, MBBS
Organizational Affiliation
Head, Pathology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans G Schneider, Associate Professor
Phone
613 9276 3118
Email
schneiderh@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Peter Cameron, Professor
Phone
613 9276 2000
Email
peter.cameron@med.monash.edu.au
First Name & Middle Initial & Last Name & Degree
Hans G Schneider, MD FRCPA FRACP
First Name & Middle Initial & Last Name & Degree
Peter Cameron, MBBS,MD,FACEM
First Name & Middle Initial & Last Name & Degree
Henry Krum, MBBS,PhD,FRACP

12. IPD Sharing Statement

Citations:
PubMed Identifier
19933409
Citation
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.
Results Reference
derived
PubMed Identifier
19293069
Citation
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.
Results Reference
derived

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BNP Testing in Patients With SOB on Presentation to ED

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