Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER

Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation Clinical Trial

— UTAPE BPCO  

Official title:

Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857947
• Other study ID #: UTAPE01
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: December 2, 2014
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: ThermoFisher Scientific Brahms Biomarkers France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).

Description:

Acute exacerbation of COPD (AECOPD)are usual and frequent cause of admission in emergency room (ER). No validated clinical or biological predictor of evolution are available.

The main objective is to determine the prognosis value of Mr proADM in addition to the clinical risk stratification for AE COPD patients in ER.

Patients presenting with a AECOPD diagnosis in ER will have a blood sample collected and freezed at their admission. Mr proADM will be assessed at the end of the study. Clinicians in charge of patients will not have the result during the management of their patients. This study implies no change in the patients' management.

Data related to the patients'demographic,current exacerbation and basic COPD characteristics will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• patients > 40 years old

• Acute exacerbation of COPD

Exclusion Criteria:

• Medico social conditions not allowing home discharge

• Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer

• Pneumonia on chest ray

• acute respiratory distress requiring immediate ICU transfer

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Disease
• Emergencies
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation

Intervention

Other:
• AECOPD Mr proADM

Locations

Country	Name	City	State
France	Hôpital Lariboisière	Paris
France	Pitié Salpétrière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
ThermoFisher Scientific Brahms Biomarkers France	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome measure	Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER	at Day 30	No
Secondary	composite outcome	Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER	at Day 7 of ER admission	No
Secondary	correlation between Mr proADM and patients Severity	Correlation between MR proADM and patient's severity	at Day 7 and Day 30 of ED admission	No