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BIOmarkers of Dyspnea IN Emergency Room (BIODINER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier:
NCT01227317
First received: October 21, 2010
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Severe Dyspnea
CAPD
AE COPD
Acute Heart Failure
Pulmonary Embolism
 Other: Prognostic value of Biomarkers

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ThermoFisher Scientific Brahms Biomarkers France:

Primary Outcome Measures:
  • prognostic value of PCT, MR proADM, Mr pro ANP, Copeptin and pro endothelin in SOB [ Time Frame: at Day 30 ] [ Designated as safety issue: No ]
    all cause mortality or Intensive Care Unit(ICU) admission from inclusion to Day 30


Secondary Outcome Measures:
  • establish the diagnostic value of PCT and MR pro ANP [ Time Frame: at admission ] [ Designated as safety issue: No ]
    Confirm the diagnostic value of PCT and it's level in sepsis and MR pro ANP in Heart failure


Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 444
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Severe acute SOB Suspicion of CAP, Acute Heart failure, AE COPD or PE

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227317

Locations
France
Emergency department of Pitié Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
ThermoFisher Scientific Brahms Biomarkers France
Investigators
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

No publications provided

Responsible Party: ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier: NCT01227317     History of Changes
Other Study ID Numbers: BIODINER BRAHMS France
Study First Received: October 21, 2010
Last Updated: December 6, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by ThermoFisher Scientific Brahms Biomarkers France:
Dyspnea
Mortality

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

ClinicalTrials.gov processed this record on June 18, 2013