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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01227317
Other study ID # BIODINER BRAHMS France
Secondary ID
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


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
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