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BIOmarkers of Dyspnea IN Emergency Room (BIODINER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01227317
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : December 7, 2011
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Severe Dyspnea CAPD AE COPD Acute Heart Failure Pulmonary Embolism Other: Prognostic value of Biomarkers

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

Study Type : Observational
Actual Enrollment : 444 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department
Study Start Date : April 2010
Primary Completion Date : August 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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)
Other: Prognostic value of Biomarkers
Mr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients
Other Names:
  • Dyspnea
  • Prognostic value

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. establish the diagnostic value of PCT and MR pro ANP [ Time Frame: at admission ]
    Confirm the diagnostic value of PCT and it's level in sepsis and MR pro ANP in Heart failure

Biospecimen Retention:   Samples Without DNA

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Severe acute SOB Suspicion of CAP, Acute Heart failure, AE COPD or PE

Inclusion Criteria:

  • tachypnea > 25 /min or Pa02 < 70 mmHg or SpO2 < 93%
  • diagnosis suspected: CAP, PE,EACOPD, AHF

Exclusion Criteria:

  • other cause of dyspnea,
  • unreachable on Day 30
Contacts and Locations

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): NCT01227317

Emergency department of Pitié Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
ThermoFisher Scientific Brahms Biomarkers France
Study Chair: Pierre Hausfater, Pr ED Pitié SalpêtrièreHospital in Paris
Principal Investigator: Yann-Erick Claessens, Dr ED Cochin Hospital in Paris
Principal Investigator: Guillaume Der Sahakian, Dr ED Hotel Dieu Hospital in Paris
Principal Investigator: Arnaud Martinage, Dr ED Hotel Dieu Hospital in Nantes
Principal Investigator: Fatima Rayeh, Dr ED La Miletrie Hospital in Poitiers
Principal Investigator: Eric Weil, Pr ED Hospital B in Lille
Principal Investigator: Luc-Marie JOLY, Dr ED Charles Nicolle Hospital in Rouen
More Information

Responsible Party: ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier: NCT01227317     History of Changes
Other Study ID Numbers: BIODINER BRAHMS France
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011

Keywords provided by ThermoFisher Scientific Brahms Biomarkers France:

Additional relevant MeSH terms:
Heart Failure
Pulmonary Embolism
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms