NCT01857947

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.6 years

First QC Date

May 16, 2013

Last Update Submit

December 2, 2014

Conditions

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

Keywords

AECOPD Mr ProADM Biomarkers ER Outcome

Outcome Measures

Primary Outcomes (1)

  • composite outcome measure

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

    at Day 30

Secondary Outcomes (2)

  • composite outcome

    at Day 7 of ER admission

  • correlation between Mr proADM and patients Severity

    at Day 7 and Day 30 of ED admission

Study Arms (1)

AECOPD Mr proADM

NO INTERVENTION

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

Interventions

AECOPD Mr proADMOTHER
AECOPD Mr proADM

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients \> 40 years old
  • Acute exacerbation of COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Lariboisière

Paris, Paris, 75010, France

Location

Pitié Salpétrière Hospital

Paris, Paris, 75013, France

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Nicolas Roche, MD PHD

    Hotel Dieu Hospital Paris

    STUDY CHAIR

  • Martin Dres, MD

    Hopital Bicêtre Le Krémlin Bicêtre

    STUDY DIRECTOR

  • Pierre Hausfater, MD PHD

    Pitié Salpétrière Hospital Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

FR(2)