Clinical Trial: Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
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 Summary:
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.
Sponsor: University of Aarhus
Current Primary Outcome: Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology [ Time Frame: Within 1 day from randomization ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology [ 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
- Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication [ Time Frame: Within 1 day ]beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids
- Length of hospital stay [ Time Frame: Up to three months from randomization ]Time from hospital admission related to the inclusion event to discharge from hospital
- Intensive care unit admission rate [ 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
- All-cause re-admission [ Time Frame: Within 3 months of randomization ]
- Proportion of patients not admitted to hospital [ Time Frame: Within 24 hours ]Proportion of patients not admitted to hospital in relation to the inclusion event
- All-cause mortality [ Time Frame: Within 30 days of randomization ]
- Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication [ Time Frame: Within 1 day ]Loop diuretics, nitrates, opiates
- Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting [ 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
- Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting [ 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
Original Secondary Outcome:
- Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology [ 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
- Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication [ Time Frame: Within 1 day ]beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids
- Length of hospital stay [ Time Frame: Up to three months from randomization ]Time from hospital admission related to the inclusion event to discharge from hospital
- Intensive care unit admission rate [ 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
- All-cause re-admission [ Time Frame: Within 3 months of randomization ]
- Proportion of patients not admitted to hospital [ Time Frame: Within 24 hours ]Proportion of patients not admitted to hospital in relation to the inclusion event
- All-cause mortality [ Time Frame: Within 30 days of randomization ]
- Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication [ Time Frame: Within 1 day ]Loop diuretics, nitrates, opiates
Information By: University of Aarhus
Dates:
Date Received: January 23, 2014
Date Started: February 2014
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016