BIOmarkers of Dyspnea IN Emergency Room (BIODINER)

December 6, 2011 updated by: ThermoFisher Scientific Brahms Biomarkers France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Emergency department of Pitié Salpetriere Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

December 7, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIODINER BRAHMS France

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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