BIOmarkers of Dyspnea IN Emergency Room

NCT01227317 | Completed DMC

• 1 other identifier: BIODINER BRAHMS France
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Dyspnea; CAPD; AE COPD; Acute Heart Failure; Pulmonary Embolism

Keywords

Dyspnea; Mortality

Outcome Measures

Primary Outcomes (1)

• 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

  at Day 30

Secondary Outcomes (1)

• establish the diagnostic value of PCT and MR pro ANP

  at admission

Study Arms (1)

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

Interventions

Prognostic value of Biomarkers OTHER

Mr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients

Also known as: Dyspnea, Prognostic value

Acute dyspnea in ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• other cause of dyspnea,
• unreachable on Day 30

Sponsors & Collaborators

• ThermoFisher Scientific Brahms Biomarkers France: lead

Study Sites (1)

Emergency department of Pitié Salpetriere Hospital

Paris, Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Dyspnea; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pierre Hausfater, Pr

  ED Pitié SalpêtrièreHospital in Paris

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

FR (1)