Severe DyspneaBIODINERNCT01227317
BIOmarkers of Dyspnea IN Emergency Room
An observational study of Severe Dyspnea and CAPD, run by ThermoFisher Scientific Brahms Biomarkers France at 1 site in France.
Trial summary
The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Dyspnea, CAPD, AE COPD
- What is being tested?
- Prognostic value of Biomarkers
- How many people
- 444 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Sep 2011
- 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: Severe acute SOB Suspicion of CAP, Acute Heart failure, AE COPD or PE
Who may be able to join
- tachypnea > 25 /min or Pa02 < 70 mmHg or SpO2 < 93%
- diagnosis suspected: CAP, PE,EACOPD, AHF
Who cannot join
- other cause of dyspnea,
- unreachable on Day 30
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency department of Pitié Salpetriere Hospital
Paris, Paris, 75013
About this study
Official title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department
The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.
Read the detailed description
In emergency department shortness of breath (SOB)is a common symptom and its cause is not easy to be identified. The risk stratifying remains a challenge, Prognostic value of biomarkers might be helpful.
- Conditions
- Severe Dyspnea, CAPD, AE COPD, Acute Heart Failure, Pulmonary Embolism
- Being tested
- Prognostic value of Biomarkers
- Keywords
- Dyspnea, Mortality
- Medical subject headings
- Dyspnea, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic value of BiomarkersOther
Also called Dyspnea, Prognostic value
Mr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients
| Study group | Role | What they receive |
|---|---|---|
| Acute dyspnea in ED | Acute severe shortness of breath (SOB) in emergency Department (ED) with suspicion of acute heart failure (AHF) or Pulmonary Embolism (PE)or Community-acquired pneumonia (CAP) or acute Exacerbation of chronic obstructive pulmonary disease (AE COPD) Receives: Other: Prognostic value of Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognostic value of PCT, MR proADM, Mr pro ANP, Copeptin and pro endothelin in SOB
all cause mortality or Intensive Care Unit(ICU) admission from inclusion to Day 30
Measured: at Day 30
Secondary outcomes (1)
establish the diagnostic value of PCT and MR pro ANP
Confirm the diagnostic value of PCT and it's level in sepsis and MR pro ANP in Heart failure
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe DyspneaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Hausfater, Pr, Study chair, ED Pitié SalpêtrièreHospital in ParisYann-Erick Claessens, Dr, Principal investigator, ED Cochin Hospital in ParisGuillaume Der Sahakian, Dr, Principal investigator, ED Hotel Dieu Hospital in ParisArnaud Martinage, Dr, Principal investigator, ED Hotel Dieu Hospital in NantesFatima Rayeh, Dr, Principal investigator, ED La Miletrie Hospital in PoitiersEric Weil, Pr, Principal investigator, ED Hospital B in LilleLuc-Marie JOLY, Dr, Principal investigator, ED Charles Nicolle Hospital in Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227317
- Sponsor's protocol ID
- BIODINER BRAHMS France
- Acronym
- BIODINER
- Status last verified
- Dec 2011
- First submitted
- 21 Oct 2010
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department
- ClinicalTrials.gov ID
- NCT01227317
- Acronym / sponsor ID
- BIODINER / BIODINER BRAHMS France
- Conditions
- Severe Dyspnea, CAPD, AE COPD, Acute Heart Failure, Pulmonary Embolism
- Keywords
- Dyspnea, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- ThermoFisher Scientific Brahms Biomarkers FranceIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- 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.
The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.
Detailed description
In emergency department shortness of breath (SOB)is a common symptom and its cause is not easy to be identified. The risk stratifying remains a challenge, Prognostic value of biomarkers might be helpful.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute dyspnea in ED | – | Other: Prognostic value of BiomarkersAcute severe shortness of breath (SOB) in emergency Department (ED) with suspicion of acute heart failure (AHF) or Pulmonary Embolism (PE)or Community-acquired pneumonia (CAP) or acute Exacerbation of chronic obstructive pulmonary disease (AE COPD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe acute SOB Suspicion of CAP, Acute Heart failure, AE COPD or PE
Key inclusion criteria (2 listed)
- tachypnea > 25 /min or Pa02 < 70 mmHg or SpO2 < 93%
- diagnosis suspected: CAP, PE,EACOPD, AHF
Key exclusion criteria (2 listed)
- other cause of dyspnea,
- unreachable on Day 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic value of BiomarkersAlso: Dyspnea, Prognostic valueMr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients | Other | Acute dyspnea in ED |
Primary outcome
prognostic value of PCT, MR proADM, Mr pro ANP, Copeptin and pro endothelin in SOB
Time frame: at Day 30
all cause mortality or Intensive Care Unit(ICU) admission from inclusion to Day 30
1 secondary outcome
establish the diagnostic value of PCT and MR pro ANP
Time frame: at admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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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.
Pierre Hausfater, Pr study chair
ED Pitié SalpêtrièreHospital in Paris
Yann-Erick Claessens, Dr principal investigator
ED Cochin Hospital in Paris
Guillaume Der Sahakian, Dr principal investigator
ED Hotel Dieu Hospital in Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Dyspnea and CAPD, run by ThermoFisher Scientific Brahms Biomarkers France at 1 site 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 2 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: finished, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognostic value of PCT, MR proADM, Mr pro ANP, Copeptin and pro endothelin in SOB (time frame: at Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2011.