Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

Dyspnea Clinical Trial

— PreBNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050282
• Other study ID #: AU-PHAD01
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: May 26, 2016
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: May 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria Age < 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspnea

Intervention

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.

Locations

Country	Name	City	State
Denmark	Critical Care Team Aarhus, Prehospital Emergency Medical Services	Aarhus	Central Denmark Region
Denmark	Critical Care Team Grenaa, Prehospital Emergency Medical Services	Grenaa	Central Denmark Region
Denmark	Critical Care Team Herning, Prehospital Emergency Medical Services	Herning	Central Denmark Region
Denmark	Critical Care Team Holstebro	Holstebro	Central Denmark Region
Denmark	Critical Care Team Horsens, Prehospital Emergency Medical Services	Horsens	Central Denmark Region
Denmark	Critical Care Team, Lemvig, Prehospital Emergency Medical Services	Lemvig	Central Denmark Region
Denmark	Critical Care Team Randers, Prehospital Emergency Medical Services	Randers	Central Denmark Region
Denmark	Critical Care Team Silkeborg, Prehospital Emergency Medical Services	Silkeborg	Central Denmark Region
Denmark	Critical Care Team, Viborg, Prehospital Emergency Medical Services	Viborg	Central Denmark Region

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology	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	Within 1 day from randomization	No
Secondary	Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication	beta2-agonist inhalations, combined ipratropium/b2-agonist inhalations, intravenous b2-agonists, intravenous corticosteroids	Within 1 day	No
Secondary	Length of hospital stay	Time from hospital admission related to the inclusion event to discharge from hospital	Up to three months from randomization	No
Secondary	Intensive care unit admission rate	Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event	Up to three months from randomization	No
Secondary	All-cause re-admission		Within 3 months of randomization	No
Secondary	Proportion of patients not admitted to hospital	Proportion of patients not admitted to hospital in relation to the inclusion event	Within 24 hours	No
Secondary	All-cause mortality		Within 30 days of randomization	No
Secondary	Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication	Loop diuretics, nitrates, opiates	Within 1 day	No
Secondary	Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting	An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value	Within 1 day of randomization	No
Secondary	Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting	An endpoint committee determines final diagnoses based on clinical and paraclinical data excluding prehospital NT-pro-BNP value	Within 1 day of randomization	No