Back to results

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

Primary Purpose

Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

AECOPD Mr proADM

About this trial

This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation focused on measuring AECOPD Mr ProADM Biomarkers ER Outcome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Lariboisière
Pitié Salpétrière Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

AECOPD Mr proADM

Arm Description

Patients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study

Outcomes

Primary Outcome Measures

composite outcome measure

Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER

Secondary Outcome Measures

composite outcome

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

Correlation between MR proADM and patient's severity

Full Information

NCT ID

NCT01857947

First Posted

May 16, 2013

Last Updated

December 2, 2014

Sponsor

ThermoFisher Scientific Brahms Biomarkers France

Collaborators

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01857947

Brief Title

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

Acronym

UTAPE BPCO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThermoFisher Scientific Brahms Biomarkers France

Collaborators

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation

Keywords

AECOPD Mr ProADM Biomarkers ER Outcome

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

370 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AECOPD Mr proADM

Arm Type

No Intervention

Arm Description

Patients involved in this study will have a simple blood sample collected for Mr proADM assessment at the end of study

Intervention Type

Other

Intervention Name(s)

AECOPD Mr proADM

Primary Outcome Measure Information:

Title

composite outcome measure

Description

Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER

Time Frame

at Day 30

Secondary Outcome Measure Information:

Title

composite outcome

Description

Death, subsequently transfer to ICU, relapse, need to be ventilated after 24 hours of their admission in ER

Time Frame

at Day 7 of ER admission

Title

correlation between Mr proADM and patients Severity

Description

Correlation between MR proADM and patient's severity

Time Frame

at Day 7 and Day 30 of ED admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Roche, MD PHD

Organizational Affiliation

Hotel Dieu Hospital Paris

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Martin Dres, MD

Organizational Affiliation

Hopital Bicêtre Le Krémlin Bicêtre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pierre Hausfater, MD PHD

Organizational Affiliation

Pitié Salpétrière Hospital Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Lariboisière

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Pitié Salpétrière Hospital

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs