BIOmarkers of Dyspnea IN Emergency Room

Pulmonary Embolism Clinical Trial

— BIODINER  

Official title:

Prognostic Value of Novel Biomarkers in Patients With Shortness of Breath Attending an Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227317
• Other study ID #: BIODINER BRAHMS France
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: December 6, 2011
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: ThermoFisher Scientific Brahms Biomarkers France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Prognostic value of Biomarkers
Mr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients

Locations

Country	Name	City	State
France	Emergency department of Pitié Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ThermoFisher Scientific Brahms Biomarkers France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	at admission	No