DyspneaPreBNPNCT02050282

Prehospital Triage of Patients With Severe Shortness of Breath Using Biomarkers

A study testing Supplementary NT-proBNP measurement in people with Dyspnea, run by University of Aarhus at 9 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyspnea
What is being tested?: Supplementary NT-proBNP measurement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 712 participants
Where: 9 sitesDenmark
Study dates: Feb 2014to May 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Denmark9 sites

Critical Care Team Aarhus, Prehospital Emergency Medical Services
Aarhus, Central Jutland, 8200
Critical Care Team Grenaa, Prehospital Emergency Medical Services
Grenå, Central Jutland, 8500
Critical Care Team Herning, Prehospital Emergency Medical Services
Herning, Central Jutland, 7400
Critical Care Team Holstebro
Holstebro, Central Jutland, 7500
Critical Care Team Horsens, Prehospital Emergency Medical Services
Horsens, Central Jutland, 8700
Critical Care Team, Lemvig, Prehospital Emergency Medical Services
Lemvig, Central Jutland, 7620
Critical Care Team Randers, Prehospital Emergency Medical Services
Randers, Central Jutland, 8930
Critical Care Team Silkeborg, Prehospital Emergency Medical Services
Silkeborg, Central Jutland, 8600
Critical Care Team, Viborg, Prehospital Emergency Medical Services
Viborg, Central Jutland, 8800

Other trials in Denmark

About this study

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

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

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
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

Read the 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
Being tested: Supplementary NT-proBNP measurement
Keywords: Dyspnea, Prehospital, Biomarker, Heart failure, Triage, Randomized, controlled study
Medical subject headings: Dyspnea, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supplementary NT-proBNP measurementOther
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.

Study groups in NCT02050282
Study group	Role	What they receive
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 Receives: Other: Supplementary NT-proBNP measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Within 1 day from randomization

Secondary outcomes (10)

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
Measured: Within 1 day from randomization
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
Measured: Within 1 day
Length of hospital stay
Time from hospital admission related to the inclusion event to discharge from hospital
Measured: Up to three months from randomization
Intensive care unit admission rate
Within the time from hospital admission related to the inclusion event to discharge from hospital related to inclusion event
Measured: Up to three months from randomization
All-cause re-admission
Measured: Within 3 months of randomization
Proportion of patients not admitted to hospital
Proportion of patients not admitted to hospital in relation to the inclusion event
Measured: Within 24 hours
All-cause mortality
Measured: Within 30 days of randomization
Proportion of patients with dyspnea caused by lung disease, that receives traditional heart failure medication
Loop diuretics, nitrates, opiates
Measured: Within 1 day
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
Measured: Within 1 day of randomization
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
Measured: Within 1 day of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014May 2016

First posted30 Jan 2014 (estimated)
Study startFeb 2014
Primary completionAug 2015
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DyspneaStudies of the same condition, open and under way.
More trials run by University of AarhusThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 712 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02050282
Sponsor's protocol ID: AU-PHAD01
Acronym: PreBNP
Status last verified: May 2016
First submitted: 23 Jan 2014
Last updated: 27 May 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 28492084

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mechanical Ventilator Adjustments and Patient Dyspnea
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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prehospital Triage of Patients With Severe Dyspnea Using Point-of-Care N-terminal Pro-Brain Natriuretic Peptide. PreBNP Trial.
ClinicalTrials.gov ID: NCT02050282
Acronym / sponsor ID: PreBNP / AU-PHAD01
Conditions: Dyspnea
Keywords: Dyspnea, Prehospital, Biomarker, Heart failure, Triage, Randomized, controlled study
Study type: Interventional
Recruitment status: Completed
Enrolment: 712 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Collaborators: Central Denmark Region, Aarhus University Hospital
Study start: Feb 2014
Primary completion: Aug 2015 (actual)
Study completion: May 2016 (actual)
First posted: 30 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

We hypothesize, that

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
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):

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Business as usual	No intervention	–Triage and treatment based on routine clinical assessment as usual
Supplementary NT-proBNP measurement	Experimental	Other: Supplementary NT-proBNP measurementTriage and treatment based on routine clinical assessment supplemented with measurement of NT-proBNP

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supplementary NT-proBNP measurementIn 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.	Other	Supplementary NT-proBNP measurement

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

10 secondary outcomes

Proportion of patients with dyspnea of other etiologies initially triaged to department of cardiology
Time frame: Within 1 day from randomization
Proportion of patients with dyspnea caused by heart disease that receives pulmonary medication
Time frame: Within 1 day
Length of hospital stay
Time frame: Up to three months from randomization
Intensive care unit admission rate
Time frame: Up to three months from randomization
All-cause re-admission
Time frame: Within 3 months of randomization
Proportion of patients not admitted to hospital
Time frame: Within 24 hours
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
Proportion of patients with correct diagnosis of congestive heart failure in the prehospital setting
Time frame: Within 1 day of randomization
Proportion of patients where congestive heart failure is correctly disproved in the prehospital setting
Time frame: Within 1 day of randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
Derived from this study: PubMed 28492084Botker 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.

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Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Morten Thingemann Bøtker, MD principal investigator

Central Denmark Region

Christian Juhl Terkelsen, MD, DmSc study director

Department of Cardiology B, Aarhus University Hospital, Skejby, Denmark

Hans Kirkegaard, Professor study chair

Aarhus University Hospital

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Supplementary NT-proBNP measurement in people with Dyspnea, run by University of Aarhus at 9 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with dyspnea caused by heart disease initially triaged to department of cardiology (time frame: Within 1 day from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02050282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.