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Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District (PURPLE) (PURPLE)

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ClinicalTrials.gov Identifier: NCT03194243
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

This is an observational prospective multicenter study of patients admitted for acute dyspnea in an emergency department of the participating centers in the Lorraine district.

The primary objective is to assess the outcome of this population according to the cause of acute dyspnea as well as identify the predictors of this outcome, both overall and according to each acute dyspnea cause.


Condition or disease
Acute Dyspnea

Detailed Description:

This observational prospective multicenter study will be conducted using data from electronic medical records, acquired as part of usual care, in patients admitted for acute dyspnea in the emergency department. Clinical, treatment, laboratory and imaging data acquired during the hospitalization (in the emergency department and in the department that admitted the patients following the emergency department stay) will be collected.

Vital status will be recorded at 30 days and 1 year post-admission.


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Study Type : Observational
Estimated Enrollment : 75000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Patients admitted for acute dyspnea
Patients admitted for acute dyspnea in the emergency department



Primary Outcome Measures :
  1. All cause mortality [ Time Frame: From emergency admission for acute dyspnea up until 1 year ]

Secondary Outcome Measures :
  1. Demographic data [ Time Frame: through hospital stay, an average of 10 days ]
  2. Clinical data [ Time Frame: through hospital stay, an average of 10 days ]
  3. Treatment data [ Time Frame: through hospital stay, an average of 10 days ]
  4. Laboratory data [ Time Frame: through hospital stay, an average of 10 days ]
  5. Imaging data [ Time Frame: through hospital stay, an average of 10 days ]
  6. Duration of hospitalization [ Time Frame: At final discharge, an average of 10 days after admission ]
    including emergency stay and conventional hospitalization

  7. Initial diagnosis in the emergency department [ Time Frame: At admission ]
  8. Final diagnosis of the initial hospitalization stay [ Time Frame: At final discharge, an average of 10 days after admission ]
  9. Brain Natriuretic Peptide [ Time Frame: Through hospital stay, an average of 10 days ]
  10. Estimated glomerular function rate [ Time Frame: Through hospital stay, an average of 10 days ]
  11. Estimated plasma volume [ Time Frame: Through hospital stay, an average of 10 days ]
  12. Liver biological biomarkers [ Time Frame: Through hospital stay, an average of 10 days ]
  13. Urea [ Time Frame: Through hospital stay, an average of 10 days ]
  14. Use of non-invasive ventilation [ Time Frame: Through hospital stay, an average of 10 days ]
  15. Time of use of non-invasive ventilation [ Time Frame: Through hospital stay, an average of 10 days ]
  16. Use of diuretics [ Time Frame: Through hospital stay, an average of 10 days ]
  17. Time of use of diuretics [ Time Frame: Through hospital stay, an average of 10 days ]
  18. Use of nitrates [ Time Frame: Through hospital stay, an average of 10 days ]
  19. Time of use of nitrates [ Time Frame: Through hospital stay, an average of 10 days ]
  20. Department type admitting the patient following emergency management [ Time Frame: Through hospital stay, an average of 10 days ]
    intensive care unit, cardiology, cardiac intensive care unit, other ...

  21. All cause in-hospital mortality [ Time Frame: At final discharge, an average of 10 days after admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute dyspnea and treated in an emergency department of the participating centers in the Lorraine district.
Criteria

Inclusion Criteria:

  • Men or women > or = 18 years.
  • Patients with acute dyspnea admitted for acute dyspnea in the emergency department.
  • Patient informed.

Exclusion Criteria:

  • Cardiorespiratory arrest.
  • Patient having expressed his or her opposition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194243


Contacts
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Contact: Tahar CHOUIHED, MD + 33 3 83 85 14 96 t.chouihed@chru-nancy.fr
Contact: Nicolas GIRERD, MD,PhD + 33 3 83 15 74 96 n.girerd@chru-nancy.fr

Locations
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France
CH Marie-Madeleine FORBACH - Service des Urgences Recruiting
Forbach, Lorraine, France, 57604
Contact: Caroline HLADNIK, MD         
Principal Investigator: Caroline HLADNIK, MD         
CH LUNEVILLE - Service des Urgences Recruiting
Lunéville, Lorraine, France, 54 301
Contact: Julie THISSE, MD         
Principal Investigator: Julie THISSE, MD         
CHR METZ-THIONVILLE- Hôpital de Mercy- Service des Urgences Recruiting
Metz, Lorraine, France, 57085
Contact: Elies ANDRE, MD         
Principal Investigator: Elies ANDRE, MD         
CHRU Nancy - Service des Urgences Recruiting
Nancy, Lorraine, France, 54000
Contact: Tahar CHOUIHED, MD    +33 3 83 85 14 96    t.chouihed@chru-nancy.fr   
Contact: Adrien BASSAND, MD    + 33 3 83 85 14 96    a.bassand@chru-nancy.fr   
Principal Investigator: Tahar CHOUIHED, MD         
Sub-Investigator: Adrien BASSAND, MD         
CH PONT A MOUSSON- Service des Urgences Recruiting
Pont-à-Mousson, Lorraine, France, 54 701
Contact: Alexandre GROSJEAN, MD         
Principal Investigator: Alexandre GROSJEAN, MD         
CH REMIREMONT - Service des Urgences Recruiting
Remiremont, Lorraine, France, 88204
Contact: Marie BREFFA, MD         
Principal Investigator: Marie BREFFA, MD         
CH SAINT-DIE-DES-VOSGES - Service des Urgences Recruiting
Saint-Dié-des-Vosges, Lorraine, France, 88100
Contact: Patrice THIRION, MD         
Principal Investigator: Patrice THIRION, MD         
CHR METZ-THIONVILLE- Hôpital Bel-Air- Service des Urgences Recruiting
Thionville, Lorraine, France, 57100
Contact: Phillippe SATTONNET, MD         
Principal Investigator: Phillippe SATTONNET, MD         
CH EPINAL - Service des Urgences Recruiting
Épinal, Lorraine, France, 88021
Contact: Céline HOMEL, MD         
Principal Investigator: Céline HOMEL, MD         
Sub-Investigator: Jean-Dominique RISSER, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Tahar CHOUIHED, MD Central Hospital, Nancy, France
Principal Investigator: Nicolas GIRERD, MD,PhD Central Hospital, Nancy, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03194243     History of Changes
Other Study ID Numbers: 2016-A01877-44
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
acute dyspnea
acute heart failure
emergency
Additional relevant MeSH terms:
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Dyspnea
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms