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

  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 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 ]

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


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