Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

NCT02050282 | Completed

• 1 other identifier: AU-PHAD01
• Study Type: interventional
• Target: 712
• Locations: 1 country
• Sites: 9

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. 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. 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

Dyspnea

Keywords

Dyspnea; Prehospital; Biomarker; Heart failure; Triage; Randomized, controlled study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology

  Within 1 day from randomization

• Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication

  Within 1 day

• Length of hospital stay

  Up to three months from randomization

• Intensive care unit admission rate

  Up to three months from randomization

• All-cause re-admission

  Within 3 months of randomization

Study Arms (2)

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

Other: Supplementary NT-proBNP measurement

Interventions

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.

Supplementary NT-proBNP measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring dispatch of emergency physician because of severe dyspnea.
• Severe dyspnea is defined by dyspnea plus at least ONE of the following
• Respiration frequency \> 20 or \< 8
• Saturation \< 96 without supplementary oxygen
• Heart rate \> 100 or \< 50
• Systolic blood pressure \< 100 or \> 200
• Difficulty talking
• Central or peripheral cyanosis
• Use of accessory muscles of respiration
• Glasgow coma scale score \< 15
• AND because of the physical condition, the patient is not able to give informed consent

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator
• Aarhus University Hospital: collaborator

Study Sites (9)

Critical Care Team Aarhus, Prehospital Emergency Medical Services

Aarhus, Central Jutland, 8200, Denmark

Location

Critical Care Team Grenaa, Prehospital Emergency Medical Services

Grenå, Central Jutland, 8500, Denmark

Location

Critical Care Team Herning, Prehospital Emergency Medical Services

Herning, Central Jutland, 7400, Denmark

Location

Critical Care Team Holstebro

Holstebro, Central Jutland, 7500, Denmark

Location

Critical Care Team Horsens, Prehospital Emergency Medical Services

Horsens, Central Jutland, 8700, Denmark

Location

Critical Care Team, Lemvig, Prehospital Emergency Medical Services

Lemvig, Central Jutland, 7620, Denmark

Location

Critical Care Team Randers, Prehospital Emergency Medical Services

Randers, Central Jutland, 8930, Denmark

Location

Critical Care Team Silkeborg, Prehospital Emergency Medical Services

Silkeborg, Central Jutland, 8600, Denmark

Location

Critical Care Team, Viborg, Prehospital Emergency Medical Services

Viborg, Central Jutland, 8800, Denmark

Location

Related Publications (1)

• 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.

  PMID: 28492084 DERIVED

MeSH Terms

Conditions

Dyspnea; Heart Failure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 30, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

DK (9)