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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation
• Interventions: Other: AECOPD Mr proADM

• Registration Number: NCT01857947
• Lead Sponsor: ThermoFisher Scientific Brahms Biomarkers France

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Primary Completion: 2014-10
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AECOPD Mr proADM	AECOPD Mr proADM	Patients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study

Primary Outcome Measures

Name	Time	Method
composite outcome measure	at Day 30	Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER

Secondary Outcome Measures

Name	Time	Method
composite outcome	at Day 7 of ER admission	Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER
correlation between Mr proADM and patients Severity	at Day 7 and Day 30 of ED admission	Correlation between MR proADM and patient's severity

Trial Locations

Locations (2)

Hôpital Lariboisière; 🇫🇷 Paris, France

Pitié Salpétrière Hospital; 🇫🇷 Paris, France