Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers (PreBNP)
Primary Purpose
Dyspnea
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supplementary NT-proBNP measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyspnea focused on measuring Dyspnea, Prehospital, Biomarker, Heart failure, Triage, Randomized, controlled study
Eligibility Criteria
Inclusion Criteria:
All patients requiring dispatch of emergency physician because of severe dyspnea.
Severe dyspnea is defined by dyspnea plus at least ONE of the following
- Respiration frequency > 20 or < 8
- Saturation < 96 without supplementary oxygen
- Heart rate > 100 or < 50
- Systolic blood pressure < 100 or > 200
- Difficulty talking
- Central or peripheral cyanosis
- Use of accessory muscles of respiration
- Glasgow coma scale score < 15
AND because of the physical condition, the patient is not able to give informed consent
Exclusion Criteria Age < 18
Sites / Locations
- Critical Care Team Aarhus, Prehospital Emergency Medical Services
- Critical Care Team Grenaa, Prehospital Emergency Medical Services
- Critical Care Team Herning, Prehospital Emergency Medical Services
- Critical Care Team Holstebro
- Critical Care Team Horsens, Prehospital Emergency Medical Services
- Critical Care Team, Lemvig, Prehospital Emergency Medical Services
- Critical Care Team Randers, Prehospital Emergency Medical Services
- Critical Care Team Silkeborg, Prehospital Emergency Medical Services
- Critical Care Team, Viborg, Prehospital Emergency Medical Services
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Business as usual
Supplementary NT-proBNP measurement
Arm Description
Triage and treatment based on routine clinical assessment as usual
Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP
Outcomes
Primary Outcome Measures
Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology
An endpoint committee determines final diagnoses as "dyspnea caused by heart disease", "dyspnea caused by lung disease" and "dyspnea caused by other diseases" based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Secondary Outcome Measures
Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology
An endpoint committee determines final diagnoses as "dyspnea of cardiac origin" and "dyspnea of non-cardiac origin" based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication
beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids
Length of hospital stay
Time from hospital admission related to the inclusion event to discharge from hospital
Intensive care unit admission rate
Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event
All-cause re-admission
Proportion of patients not admitted to hospital
Proportion of patients not admitted to hospital in relation to the inclusion event
All-cause mortality
Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication
Loop diuretics, nitrates, opiates
Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting
An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting
An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Full Information
NCT ID
NCT02050282
First Posted
January 23, 2014
Last Updated
May 26, 2016
Sponsor
University of Aarhus
Collaborators
Central Denmark Region, Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02050282
Brief Title
Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
Acronym
PreBNP
Official Title
Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Central Denmark Region, Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breathlessness is a dangerous symptom. Preliminary data from national and regional Danish databases show, that patients with shortness of breath in the ambulance have a very high mortality. Breathlessness can be caused by many different conditions - but heart diseases and lung diseases are dominant. The mortality is especially high in patients with breathlessness caused by heart disease.
Distinguishing these different causes of breathlessness is a classical, often difficult, discipline in medicine. Visitation and guidance of treatment in patients with breathlessness in the prehospital setting relies on medical history and physical examination and as a consequence prehospital treatment for breathlessness is often non-specific. The use of heart-failure specific biomarkers may improve prehospital visitation and treatment of patients with breathlessness.
We hypothesize, that
Supplementing the routine examination by prehospital anesthesiologist with measurement of a biomarker for heart failure increases the proportion of patients with severe shortness of breath caused by heart disease triaged directly to department of cardiology
This strategy does not increase the proportion of patients with severe shortness of breath caused by non-heart disease triaged directly to department of cardiology
Detailed Description
Measurement of the biomarker for heart failure N-terminal pro-Brain Natriuretic Peptide (NT-proBNP):
In patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted. This will be analyzed point-of-care in the ambulance.
Interpretation of NT-proBNP:
Cut-off values based on bootstrap-validated optimal cut-points for heart failure on will be used.
Confirmatory ('rule in') cut point
< 50 years: 450 pg/mL
50-75 years: 900 pg/mL
> 75 years: 1800 pg/mL
Exclusionary ('rule out') cut point
All patients: 300 pg/mL
The emergency physicians will be thoroughly informed about these cut-points, but told not to triage to department of cardiology or other department strictly according to NT-proBNP, but according to clinical assessment AND NT-proBNP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Dyspnea, Prehospital, Biomarker, Heart failure, Triage, Randomized, controlled study
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
712 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Business as usual
Arm Type
No Intervention
Arm Description
Triage and treatment based on routine clinical assessment as usual
Arm Title
Supplementary NT-proBNP measurement
Arm Type
Experimental
Arm Description
Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP
Intervention Type
Other
Intervention Name(s)
Supplementary NT-proBNP measurement
Intervention Description
In patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted and analyzed immediately using a COBAS H232 and Roche Diagnostics NT-proBNP assay.
Primary Outcome Measure Information:
Title
Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology
Description
An endpoint committee determines final diagnoses as "dyspnea caused by heart disease", "dyspnea caused by lung disease" and "dyspnea caused by other diseases" based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Time Frame
Within 1 day from randomization
Secondary Outcome Measure Information:
Title
Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology
Description
An endpoint committee determines final diagnoses as "dyspnea of cardiac origin" and "dyspnea of non-cardiac origin" based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Time Frame
Within 1 day from randomization
Title
Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication
Description
beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids
Time Frame
Within 1 day
Title
Length of hospital stay
Description
Time from hospital admission related to the inclusion event to discharge from hospital
Time Frame
Up to three months from randomization
Title
Intensive care unit admission rate
Description
Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event
Time Frame
Up to three months from randomization
Title
All-cause re-admission
Time Frame
Within 3 months of randomization
Title
Proportion of patients not admitted to hospital
Description
Proportion of patients not admitted to hospital in relation to the inclusion event
Time Frame
Within 24 hours
Title
All-cause mortality
Time Frame
Within 30 days of randomization
Title
Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication
Description
Loop diuretics, nitrates, opiates
Time Frame
Within 1 day
Title
Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting
Description
An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Time Frame
Within 1 day of randomization
Title
Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting
Description
An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
Time Frame
Within 1 day of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients requiring dispatch of emergency physician because of severe dyspnea.
Severe dyspnea is defined by dyspnea plus at least ONE of the following
Respiration frequency > 20 or < 8
Saturation < 96 without supplementary oxygen
Heart rate > 100 or < 50
Systolic blood pressure < 100 or > 200
Difficulty talking
Central or peripheral cyanosis
Use of accessory muscles of respiration
Glasgow coma scale score < 15
AND because of the physical condition, the patient is not able to give informed consent
Exclusion Criteria Age < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Thingemann Bøtker, MD
Organizational Affiliation
Central Denmark Region
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Juhl Terkelsen, MD, DmSc
Organizational Affiliation
Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hans Kirkegaard, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erika Frischknecht Christensen, MD
Organizational Affiliation
Central Denmark Region
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thorbjørn Grøfte, MD, PhD
Organizational Affiliation
Central Denmark Region
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carsten Stengaard, MD, PhD
Organizational Affiliation
Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Critical Care Team Aarhus, Prehospital Emergency Medical Services
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Critical Care Team Grenaa, Prehospital Emergency Medical Services
City
Grenaa
State/Province
Central Denmark Region
ZIP/Postal Code
8500
Country
Denmark
Facility Name
Critical Care Team Herning, Prehospital Emergency Medical Services
City
Herning
State/Province
Central Denmark Region
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Critical Care Team Holstebro
City
Holstebro
State/Province
Central Denmark Region
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Critical Care Team Horsens, Prehospital Emergency Medical Services
City
Horsens
State/Province
Central Denmark Region
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Critical Care Team, Lemvig, Prehospital Emergency Medical Services
City
Lemvig
State/Province
Central Denmark Region
ZIP/Postal Code
7620
Country
Denmark
Facility Name
Critical Care Team Randers, Prehospital Emergency Medical Services
City
Randers
State/Province
Central Denmark Region
ZIP/Postal Code
8930
Country
Denmark
Facility Name
Critical Care Team Silkeborg, Prehospital Emergency Medical Services
City
Silkeborg
State/Province
Central Denmark Region
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Critical Care Team, Viborg, Prehospital Emergency Medical Services
City
Viborg
State/Province
Central Denmark Region
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28492084
Citation
Botker MT, Jorgensen MT, Stengaard C, Seidenfaden SC, Tarpgaard M, Granfeldt A, Mortensen TO, Grofte T, Friesgaard KD, Maerkedahl R, Pedersen AB, Lundorff S, Hansen TM, Kirkegaard H, Christensen EF, Terkelsen CJ. Prehospital triage of patients suffering severe dyspnoea using N-terminal pro-brain natriuretic peptide, the PreBNP trial: a randomised controlled clinical trial. Eur Heart J Acute Cardiovasc Care. 2018 Jun;7(4):302-310. doi: 10.1177/2048872617709985. Epub 2017 May 11.
Results Reference
derived
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Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
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