Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005871

Trial Description

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Title

EUROpean Dyspnoea Survey in the EMergency Departments

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Trial Acronym

EURODEM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing
discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms
patients can experience; and it is one of the main complaints in the patients presenting to
the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac,
pulmonary or metabolic etiologies or a combination of them, since several diseases can cause
dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary
disease (COPD).

Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in
heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure
(HF) is one of the most important causes of morbidity and mortality in the industrialized
world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general
European population. The incidence increases rapidly with age, and in Europe.
Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to
hospital have been adequately described, in Europe and in the United States. The Euro Heart
Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely
hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for
AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.

This same sensation of breathlessness is what also drives patients with asthma and chronic
obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD)
exacerbation accounts for approximately 1.5 million ED visits in the United States per year.
It is the third most common cause of hospitalization, with an estimated 726 000
hospitalizations in 2000 in the USA. Previous studies have demonstrated important
differences between guideline recommendations and actual management of COPD exacerbation,
either in the ED or during hospitalization.

The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low
sensitivity of the clinical signs associated with the aging of the population and the
variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients
in the ED at the European level. Diagnosis, prevalence and treatment of the patients may
vary among European countries.

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Brief Summary in Scientific Language

MAIN OBJECTIVES

- Epidemiologic description of patients presenting to the ED with shortness of breath as
main complaint.

- Description of current management in the ED of patients presenting to the ED with
shortness of breath as main complaint.

SECONDARY OBJECTIVES

- Sub analysis of ED discharged patients versus admitted patients for characteristics,
comparison to recommended care and re-ED visit.

- Determine clinical and/or biological criteria to distinguish between:

- Patients who are treated as outpatients and admitted patients.

- Patients hospitalized in ward and patients admitted to intensive care units (CCU
and ICU)

- Prognostic prediction, using clinical and biochemical data

- To determine if ED patients treated for acute heart failure differ from those admitted
to hospital.

- Comparison of European data characteristics, investigation, treatment and outcome to
similar data in other part of the world.

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Organizational Data

  •   DRKS00005871
  •   2014/09/10
  •   2014/02/09
  •   yes
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Secondary IDs

  •   NCT02060799  (ClinicalTrials.gov)
  •   HLariboisiere  (Hopital Lariboisière)
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Health Condition or Problem studied

  •   Dyspnea
  •   Emergencies
  •   R06.0 -  Dyspnoea
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- All cause mortality; time frame: 30 days; All cause mortality will be evaluated 30 days after ED visit.

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Secondary Outcome

- All cause rehospitalization; time frame: 30 days

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Countries of Recruitment

  •   Belgium
  •   Finland
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Romania
  •   Spain
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/02/27
  •   2500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Consecutive patients presenting to the Emergency Department with Dyspnea as main
complaint

- 18 years or older

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Exclusion Criteria

- No acceptance to participate from the patient

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hopital Lariboisière
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    • European Society for Emergency Medicine
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    • Lariboisière Hospital, EuSEM
    • Said LARIBI, MD, PhD 
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    • Said LARIBI, MD, PhD. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.