Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
NCT ID: NCT02050282
Last Updated: 2016-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
712 participants
INTERVENTIONAL
2014-02-28
2016-05-31
Brief Summary
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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
1. 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
2. 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Business as usual
Triage and treatment based on routine clinical assessment as usual
No interventions assigned to this group
Supplementary NT-proBNP measurement
Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP
Supplementary NT-proBNP measurement
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.
Interventions
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Supplementary NT-proBNP measurement
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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Central Denmark Region
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Morten Thingemann Bøtker
MD, PhD student
Principal Investigators
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Morten Thingemann Bøtker, MD
Role: PRINCIPAL_INVESTIGATOR
Central Denmark Region
Christian Juhl Terkelsen, MD, DmSc
Role: STUDY_DIRECTOR
Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
Hans Kirkegaard, Professor
Role: STUDY_CHAIR
Aarhus University Hospital
Erika Frischknecht Christensen, MD
Role: STUDY_CHAIR
Central Denmark Region
Thorbjørn Grøfte, MD, PhD
Role: STUDY_CHAIR
Central Denmark Region
Carsten Stengaard, MD, PhD
Role: STUDY_CHAIR
Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
Locations
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Critical Care Team Aarhus, Prehospital Emergency Medical Services
Aarhus, Central Jutland, Denmark
Critical Care Team Grenaa, Prehospital Emergency Medical Services
Grenå, Central Jutland, Denmark
Critical Care Team Herning, Prehospital Emergency Medical Services
Herning, Central Jutland, Denmark
Critical Care Team Holstebro
Holstebro, Central Jutland, Denmark
Critical Care Team Horsens, Prehospital Emergency Medical Services
Horsens, Central Jutland, Denmark
Critical Care Team, Lemvig, Prehospital Emergency Medical Services
Lemvig, Central Jutland, Denmark
Critical Care Team Randers, Prehospital Emergency Medical Services
Randers, Central Jutland, Denmark
Critical Care Team Silkeborg, Prehospital Emergency Medical Services
Silkeborg, Central Jutland, Denmark
Critical Care Team, Viborg, Prehospital Emergency Medical Services
Viborg, Central Jutland, Denmark
Countries
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References
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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.
Other Identifiers
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AU-PHAD01
Identifier Type: -
Identifier Source: org_study_id
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