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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

Tracking Information
First Submitted Date  ICMJE May 16, 2013
First Posted Date  ICMJE May 20, 2013
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER
Official Title  ICMJE Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation
Intervention  ICMJE Other: AECOPD Mr proADM
Study Arms  ICMJE 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
Intervention: Other: AECOPD Mr proADM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2013)
370
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857947
Other Study ID Numbers  ICMJE UTAPE01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ThermoFisher Scientific Brahms Biomarkers France
Study Sponsor  ICMJE ThermoFisher Scientific Brahms Biomarkers France
Collaborators  ICMJE Assistance Publique - Hôpitaux de Paris
Investigators  ICMJE
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
PRS Account ThermoFisher Scientific Brahms Biomarkers France
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP