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

NCT ID: NCT01857947

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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AECOPD Mr proADM

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

Group Type NO_INTERVENTION

AECOPD Mr proADM

Intervention Type OTHER

Interventions

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AECOPD Mr proADM

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

ThermoFisher Scientific Brahms Biomarkers France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Roche, MD PHD

Role: STUDY_CHAIR

Hotel Dieu Hospital Paris

Martin Dres, MD

Role: STUDY_DIRECTOR

Hopital Bicêtre Le Krémlin Bicêtre

Pierre Hausfater, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Hospital Paris

Locations

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Hôpital Lariboisière

Paris, Paris, France

Site Status

Pitié Salpétrière Hospital

Paris, Paris, France

Site Status

Countries

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France

Other Identifiers

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UTAPE01

Identifier Type: -

Identifier Source: org_study_id