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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

Tracking Information
First Submitted Date May 29, 2017
First Posted Date June 21, 2017
Last Update Posted Date October 10, 2017
Actual Study Start Date October 5, 2017
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2017)
All cause mortality [ Time Frame: From emergency admission for acute dyspnea up until 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03194243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 20, 2017)
  • Demographic data [ Time Frame: through hospital stay, an average of 10 days ]
  • Clinical data [ Time Frame: through hospital stay, an average of 10 days ]
  • Treatment data [ Time Frame: through hospital stay, an average of 10 days ]
  • Laboratory data [ Time Frame: through hospital stay, an average of 10 days ]
  • Imaging data [ Time Frame: through hospital stay, an average of 10 days ]
  • Duration of hospitalization [ Time Frame: At final discharge, an average of 10 days after admission ]
    including emergency stay and conventional hospitalization
  • Initial diagnosis in the emergency department [ Time Frame: At admission ]
  • Final diagnosis of the initial hospitalization stay [ Time Frame: At final discharge, an average of 10 days after admission ]
  • Brain Natriuretic Peptide [ Time Frame: Through hospital stay, an average of 10 days ]
  • Estimated glomerular function rate [ Time Frame: Through hospital stay, an average of 10 days ]
  • Estimated plasma volume [ Time Frame: Through hospital stay, an average of 10 days ]
  • Liver biological biomarkers [ Time Frame: Through hospital stay, an average of 10 days ]
  • Urea [ Time Frame: Through hospital stay, an average of 10 days ]
  • Use of non-invasive ventilation [ Time Frame: Through hospital stay, an average of 10 days ]
  • Time of use of non-invasive ventilation [ Time Frame: Through hospital stay, an average of 10 days ]
  • Use of diuretics [ Time Frame: Through hospital stay, an average of 10 days ]
  • Time of use of diuretics [ Time Frame: Through hospital stay, an average of 10 days ]
  • Use of nitrates [ Time Frame: Through hospital stay, an average of 10 days ]
  • Time of use of nitrates [ Time Frame: Through hospital stay, an average of 10 days ]
  • 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 ...
  • All cause in-hospital mortality [ Time Frame: At final discharge, an average of 10 days after admission ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District (PURPLE)
Official Title Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Dyspnea
Intervention Not Provided
Study Groups/Cohorts Patients admitted for acute dyspnea
Patients admitted for acute dyspnea in the emergency department
Publications * Buessler A, Chouihed T, Duarte K, Bassand A, Huot-Marchand M, Gottwalles Y, Pénine A, André E, Nace L, Jaeger D, Kobayashi M, Coiro S, Rossignol P, Girerd N. Accuracy of Several Lung Ultrasound Methods for the Diagnosis of Acute Heart Failure in the ED: A Multicenter Prospective Study. Chest. 2019 Aug 2. pii: S0012-3692(19)31393-5. doi: 10.1016/j.chest.2019.07.017. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 20, 2017)
75000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03194243
Other Study ID Numbers 2016-A01877-44
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Central Hospital, Nancy, France
Study Sponsor Central Hospital, Nancy, France
Collaborators Not Provided
Investigators
Principal Investigator: Tahar CHOUIHED, MD Central Hospital, Nancy, France
Principal Investigator: Nicolas GIRERD, MD,PhD Central Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date October 2017