Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

NCT02050282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 712

Last updated 2016-05-27

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Morten Thingemann Bøtker, MD · Central Denmark Region

  • Christian Juhl Terkelsen, MD, DmSc · Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark

  • Hans Kirkegaard, Professor · Aarhus University Hospital

  • Erika Frischknecht Christensen, MD · Central Denmark Region

  • Thorbjørn Grøfte, MD, PhD · Central Denmark Region

  • Carsten Stengaard, MD, PhD · Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-08-31
Completion
2016-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02050282 on ClinicalTrials.gov