NCT02050282

Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 712 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspnea

Interventions

Type	Name	Description
OTHER	Supplementary NT-proBNP measurement	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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-08-01
• Completion: 2016-05-01
• First posted: 2014-01-30
• Last updated: 2016-05-27

Locations

9 sites across 1 country: Denmark