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

December 2, 2014 updated by: ThermoFisher Scientific Brahms Biomarkers France

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75013
        • Pitié Salpétrière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Day 7 of ER admission
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
at Day 7 and Day 30 of ED admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThermoFisher Scientific Brahms Biomarkers France

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • 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, Pitie Salpetriere Hospital Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTAPE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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