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| Name | Class |
|---|---|
| Central Denmark Region | OTHER |
| Aarhus University Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Business as usual | No Intervention | Triage and treatment based on routine clinical assessment as usual | |
| Supplementary NT-proBNP measurement | Experimental | Triage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementary NT-proBNP measurement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 day from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 day from randomization |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Morten Thingemann Bøtker, MD | Central Denmark Region | Principal Investigator |
| Christian Juhl Terkelsen, MD, DmSc | Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark | Study Director |
| Hans Kirkegaard, Professor | Aarhus University Hospital | Study Chair |
| Erika Frischknecht Christensen, MD | Central Denmark Region | Study Chair |
| Thorbjørn Grøfte, MD, PhD | Central Denmark Region | Study Chair |
| Carsten Stengaard, MD, PhD | Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Team Aarhus, Prehospital Emergency Medical Services | Aarhus | Central Jutland | 8200 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28492084 | Derived | 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. |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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|
| 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 |
| Within 1 day |
| Length of hospital stay | Time from hospital admission related to the inclusion event to discharge from hospital | Up to three months from randomization |
| Intensive care unit admission rate | Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event | Up to three months from randomization |
| All-cause re-admission | Within 3 months of randomization |
| Proportion of patients not admitted to hospital | Proportion of patients not admitted to hospital in relation to the inclusion event | Within 24 hours |
| All-cause mortality | Within 30 days of randomization |
| Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication | Loop diuretics, nitrates, opiates | Within 1 day |
| 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 | Within 1 day of randomization |
| 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 | Within 1 day of randomization |
| Critical Care Team Grenaa, Prehospital Emergency Medical Services |
| Grenå |
| Central Jutland |
| 8500 |
| Denmark |
| Critical Care Team Herning, Prehospital Emergency Medical Services | Herning | Central Jutland | 7400 | Denmark |
| Critical Care Team Holstebro | Holstebro | Central Jutland | 7500 | Denmark |
| Critical Care Team Horsens, Prehospital Emergency Medical Services | Horsens | Central Jutland | 8700 | Denmark |
| Critical Care Team, Lemvig, Prehospital Emergency Medical Services | Lemvig | Central Jutland | 7620 | Denmark |
| Critical Care Team Randers, Prehospital Emergency Medical Services | Randers | Central Jutland | 8930 | Denmark |
| Critical Care Team Silkeborg, Prehospital Emergency Medical Services | Silkeborg | Central Jutland | 8600 | Denmark |
| Critical Care Team, Viborg, Prehospital Emergency Medical Services | Viborg | Central Jutland | 8800 | Denmark |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |