Prognosis Value of Pro-adrenomedullin in Acute Exacerbations of COPD in ER (UTAPE BPCO)
|ClinicalTrials.gov Identifier: NCT01857947|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation||Other: AECOPD Mr proADM||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Single Group Assignment|
|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|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857947
|Paris, France, 75010|
|Pitié Salpétrière Hospital|
|Paris, France, 75013|
|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|