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Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER (UTAPE BPCO)

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ClinicalTrials.gov Identifier: NCT01857947
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
ThermoFisher Scientific Brahms Biomarkers France

Study Description
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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).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation Other: AECOPD Mr proADM Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room
Study Start Date : March 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
No Intervention: AECOPD Mr proADM
Patients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study
 Other: AECOPD Mr proADM


Outcome Measures
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Primary Outcome Measures :
  1. composite outcome measure [ Time Frame: at Day 30 ]
    Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER


Secondary Outcome Measures :
  1. composite outcome [ Time Frame: at Day 7 of ER admission ]
    Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER

  2. correlation between Mr proADM and patients Severity [ Time Frame: at Day 7 and Day 30 of ED admission ]
    Correlation between MR proADM and patient's severity


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857947


Locations
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France
Hôpital Lariboisière
Paris, France, 75010
Pitié Salpétrière Hospital
Paris, France, 75013
Sponsors and Collaborators
ThermoFisher Scientific Brahms Biomarkers France
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Nicolas Roche, MD PHD Hotel Dieu Hospital Paris
Study Director: Martin Dres, MD Hopital Bicêtre Le Krémlin Bicêtre
Principal Investigator: Pierre Hausfater, MD PHD Pitié Salpétrière Hospital Paris
More Information
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Responsible Party: ThermoFisher Scientific Brahms Biomarkers France
ClinicalTrials.gov Identifier: NCT01857947    
Other Study ID Numbers: UTAPE01
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by ThermoFisher Scientific Brahms Biomarkers France:
AECOPD Mr ProADM Biomarkers ER Outcome
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Emergencies
Lung Diseases
Respiratory Tract Diseases
 Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive