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Completed

NCT Number: NCT01857947

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

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).

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lariboisière, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AECOPD Mr proADM

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ThermoFisher Scientific Brahms Biomarkers France

Industry

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

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

Acronym: UTAPE BPCO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 20, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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