Acute DyspneaPURPLENCT03194243
Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District (PURPLE)
An observational study of Acute Dyspnea, run by Central Hospital, Nancy, France at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Dyspnea
- How many people
- 75,000 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Oct 2017to Oct 2023
- Phase
- Observational
- 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
Study population: Patients with acute dyspnea and treated in an emergency department of the participating centers in the Lorraine district.
Who may be able to join
- Men or women > or = 18 years.
- Patients with acute dyspnea admitted for acute dyspnea in the emergency department.
- Patient informed.
Who cannot join
- Cardiorespiratory arrest.
- Patient having expressed his or her opposition.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CH EPINAL - Service des Urgences
Épinal, Lorraine, 88021
Céline HOMEL, MD
Céline HOMEL, MD
- Recruiting
CH Marie-Madeleine FORBACH - Service des Urgences
Forbach, Lorraine, 57604
Caroline HLADNIK, MD
Caroline HLADNIK, MD
- Recruiting
CH LUNEVILLE - Service des Urgences
Lunéville, Lorraine, 54 301
Julie THISSE, MD
Julie THISSE, MD
- Recruiting
CHR METZ-THIONVILLE- Hôpital de Mercy- Service des Urgences
Metz, Lorraine, 57085
Elies ANDRE, MD
Elies ANDRE, MD
- Recruiting
CHRU Nancy - Service des Urgences
Nancy, Lorraine, 54000
Tahar CHOUIHED, MD, +33 3 83 85 14 96, t.chouihed@chru-nancy.fr
Adrien BASSAND, MD, + 33 3 83 85 14 96, a.bassand@chru-nancy.fr
- Recruiting
CH PONT A MOUSSON- Service des Urgences
Pont-à-Mousson, Lorraine, 54 701
Alexandre GROSJEAN, MD
Alexandre GROSJEAN, MD
- Recruiting
CH REMIREMONT - Service des Urgences
Remiremont, Lorraine, 88204
Marie BREFFA, MD
Marie BREFFA, MD
- Recruiting
CH SAINT-DIE-DES-VOSGES - Service des Urgences
Saint-Dié, Lorraine, 88100
Patrice THIRION, MD
Patrice THIRION, MD
- Recruiting
CHR METZ-THIONVILLE- Hôpital Bel-Air- Service des Urgences
Thionville, Lorraine, 57100
Phillippe SATTONNET, MD
Phillippe SATTONNET, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Dyspnea
- Keywords
- acute dyspnea, acute heart failure, emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted for acute dyspnea | Patients admitted for acute dyspnea in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: From emergency admission for acute dyspnea up until 1 year
Secondary outcomes (21)
Demographic data
Measured: through hospital stay, an average of 10 days
Clinical data
Measured: through hospital stay, an average of 10 days
Treatment data
Measured: through hospital stay, an average of 10 days
Laboratory data
Measured: through hospital stay, an average of 10 days
Imaging data
Measured: through hospital stay, an average of 10 days
Duration of hospitalization
including emergency stay and conventional hospitalization
Measured: At final discharge, an average of 10 days after admission
Initial diagnosis in the emergency department
Measured: At admission
Final diagnosis of the initial hospitalization stay
Measured: At final discharge, an average of 10 days after admission
Brain Natriuretic Peptide
Measured: Through hospital stay, an average of 10 days
Estimated glomerular function rate
Measured: Through hospital stay, an average of 10 days
Estimated plasma volume
Measured: Through hospital stay, an average of 10 days
Liver biological biomarkers
Measured: Through hospital stay, an average of 10 days
Urea
Measured: Through hospital stay, an average of 10 days
Use of non-invasive ventilation
Measured: Through hospital stay, an average of 10 days
Time of use of non-invasive ventilation
Measured: Through hospital stay, an average of 10 days
Use of diuretics
Measured: Through hospital stay, an average of 10 days
Time of use of diuretics
Measured: Through hospital stay, an average of 10 days
Use of nitrates
Measured: Through hospital stay, an average of 10 days
Time of use of nitrates
Measured: 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 ...
Measured: Through hospital stay, an average of 10 days
All cause in-hospital mortality
Measured: At final discharge, an average of 10 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start5 Oct 2017
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
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 Acute DyspneaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tahar CHOUIHED, MD, Principal investigator, Central Hospital, Nancy, FranceNicolas GIRERD, MD,PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194243
- Sponsor's protocol ID
- 2016-A01877-44
- Acronym
- PURPLE
- Status last verified
- Oct 2017
- First submitted
- 29 May 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31381880
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District
- ClinicalTrials.gov ID
- NCT03194243
- Acronym / sponsor ID
- PURPLE / 2016-A01877-44
- Conditions
- Acute Dyspnea
- Keywords
- acute dyspnea, acute heart failure, emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Jun 2017 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted for acute dyspnea | – | –Patients admitted for acute dyspnea in the emergency department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute dyspnea and treated in an emergency department of the participating centers in the Lorraine district.
Key inclusion criteria (3 listed)
- Men or women > or = 18 years.
- Patients with acute dyspnea admitted for acute dyspnea in the emergency department.
- Patient informed.
Key exclusion criteria (2 listed)
- Cardiorespiratory arrest.
- Patient having expressed his or her opposition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: From emergency admission for acute dyspnea up until 1 year
21 secondary outcomes
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
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
All cause in-hospital mortality
Time frame: At final discharge, an average of 10 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Derived from this study: PubMed 31381880Buessler 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.
- Individual participant dataSharing planned: No
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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.
Tahar CHOUIHED, MD principal investigator
Central Hospital, Nancy, France
Nicolas GIRERD, MD,PhD principal investigator
Central Hospital, Nancy, France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Dyspnea, run by Central Hospital, Nancy, France at 9 sites in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahar CHOUIHED, MD (+ 33 3 83 85 14 96, t.chouihed@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: From emergency admission for acute dyspnea up until 1 year). 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 NCT03194243, 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 10 Oct 2017.