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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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Hôpital Lariboisière, Paris, France
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
Primary outcomes
-
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
-
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
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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