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

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 75000

Contacts and Locations

• Study Contact: Name: Tahar CHOUIHED, MD; Phone Number: + 33 3 83 85 14 96; Email: t.chouihed@chru-nancy.fr
• Study Contact Backup: Name: Nicolas GIRERD, MD,PhD; Phone Number: + 33 3 83 15 74 96; Email: n.girerd@chru-nancy.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	From emergency admission for acute dyspnea up until 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data		through hospital stay, an average of 10 days
Clinical data		through hospital stay, an average of 10 days
Treatment data		through hospital stay, an average of 10 days
Laboratory data		through hospital stay, an average of 10 days
Imaging data		through hospital stay, an average of 10 days
Duration of hospitalization	including emergency stay and conventional hospitalization	At final discharge, an average of 10 days after admission
Initial diagnosis in the emergency department		At admission
Final diagnosis of the initial hospitalization stay		At final discharge, an average of 10 days after admission
Brain Natriuretic Peptide		Through hospital stay, an average of 10 days
Estimated glomerular function rate		Through hospital stay, an average of 10 days
Estimated plasma volume		Through hospital stay, an average of 10 days
Liver biological biomarkers		Through hospital stay, an average of 10 days
Urea		Through hospital stay, an average of 10 days
Use of non-invasive ventilation		Through hospital stay, an average of 10 days
Time of use of non-invasive ventilation		Through hospital stay, an average of 10 days
Use of diuretics		Through hospital stay, an average of 10 days
Time of use of diuretics		Through hospital stay, an average of 10 days
Use of nitrates		Through hospital stay, an average of 10 days
Time of use of nitrates		Through hospital stay, an average of 10 days
Department type admitting the patient following emergency management	intensive care unit, cardiology, cardiac intensive care unit, other ...	Through hospital stay, an average of 10 days
All cause in-hospital mortality		At final discharge, an average of 10 days after admission

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Tahar CHOUIHED, MD, Central Hospital, Nancy, France; Principal Investigator: Nicolas GIRERD, MD,PhD, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Buessler A, Chouihed T, Duarte K, Bassand A, Huot-Marchand M, Gottwalles Y, Penine A, Andre 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. 2020 Jan;157(1):99-110. doi: 10.1016/j.chest.2019.07.017. Epub 2019 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: emergency; acute heart failure; acute dyspnea
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Emergencies; Dyspnea
• Other Study ID Numbers: 2016-A01877-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No