Clinical trial NCT02050282: Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
Official title: Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: Dyspnea
Prehospital
Biomarker
Heart failure
Triage
Randomized, controlled study
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: Aarhus University Hospital
First posted: 2014-01-30
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

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.

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

Primary outcomes:
measure: Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology
timeFrame: Within 1 day from randomization
Secondary outcomes:
measure: Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology
timeFrame: Within 1 day from randomization
measure: Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication
timeFrame: Within 1 day
measure: Length of hospital stay
timeFrame: Up to three months from randomization
measure: Intensive care unit admission rate
timeFrame: Up to three months from randomization
measure: All-cause re-admission
timeFrame: Within 3 months of randomization
measure: Proportion of patients not admitted to hospital
timeFrame: Within 24 hours
measure: All-cause mortality
timeFrame: Within 30 days of randomization
measure: Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication
timeFrame: Within 1 day
measure: Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting
timeFrame: Within 1 day of randomization
measure: Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting
timeFrame: Within 1 day of randomization
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Critical Care Team Aarhus, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Grenaa
country: Denmark
facility: Critical Care Team Grenaa, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Herning
country: Denmark
facility: Critical Care Team Herning, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Holstebro
country: Denmark
facility: Critical Care Team Holstebro
state: Central Denmark Region
city: Horsens
country: Denmark
facility: Critical Care Team Horsens, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Lemvig
country: Denmark
facility: Critical Care Team, Lemvig, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Randers
country: Denmark
facility: Critical Care Team Randers, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Silkeborg
country: Denmark
facility: Critical Care Team Silkeborg, Prehospital Emergency Medical Services
state: Central Denmark Region
city: Viborg
country: Denmark
facility: Critical Care Team, Viborg, Prehospital Emergency Medical Services
state: Central Denmark Region
Study officials:
affiliation: Central Denmark Region
name: Morten Thingemann Bøtker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
name: Christian Juhl Terkelsen, MD, DmSc
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital
name: Hans Kirkegaard, Professor
role: STUDY_CHAIR
affiliation: Central Denmark Region
name: Erika Frischknecht Christensen, MD
role: STUDY_CHAIR
affiliation: Central Denmark Region
name: Thorbjørn Grøfte, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark
name: Carsten Stengaard, MD, PhD
role: STUDY_CHAIR
References:
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.