NCT Number: NCT02050282
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Critical Care Team Aarhus, Prehospital Emergency Medical Services, Aarhus, Central Jutland, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
AND because of the physical condition, the patient is not able to give informed consent
Exclusion criteria
Age < 18
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.
Time frame: Within 1 day from randomization
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
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
beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids
Time frame: Up to three months from randomization
Time from hospital admission related to the inclusion event to discharge from hospital
Time frame: Up to three months from randomization
Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event
Time frame: Within 3 months of randomization
Time frame: Within 24 hours
Proportion of patients not admitted to hospital in relation to the inclusion event
Time frame: Within 30 days of randomization
Time frame: Within 1 day
Loop diuretics, nitrates, opiates
Time frame: Within 1 day of randomization
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
An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value
University of Aarhus
Other
Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
Acronym: PreBNP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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