Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units (REXECOR)

October 11, 2020 updated by: Rexecor

Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).

Secondary objectives will be:

to assess efficacy and safety of ECCO2R,
to compare the data issue from the registry to others studies assessing the same population and to other centers and
to compare the different ECCOR devices in terms of efficacy and adverse events.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: ECCO2R

Detailed Description

The registry will be conducted prospectively during 2 years in 10 ICUs of l'APHP on behalf on the CEDIT. The 10 centers are : (1) ICU of l'hôpital europeén Georges Pompidou, (2) ICU of l'Hôpital Louis Mourier, (3) ICU of l'Hôpital de Bicêtre, (4) ICU of GHPS, (5) Respiratory ICU of GHPS, (6) ICU of l'Hôpital Lariboisière (7) ICU of l'Hôpital Cochin (8) ICU of l'Hôpital Saint-Antoine (9)ICU of l'Hôpital Henri Mondor and (10) ICU of l'Hôpital Tenon.

The primary outcome will be the number of patients implanted by ECCO2R monthly in each center during the 2 years period study.

Secondary outcomes will be ICU-mortality, invasive ventilation duration, non invasive ventilation duration, ICU duration, modalities of ventilation at the ICU discharge, hemorragic complications due to the ECCOR device, thrombotic complications due to ECCO2R device, intravascular hemolysis due to ECCO2R device, duration of ECCO2R, adjunct therapy to ECCO2R and reasons of ECCO2R discontinuation.

Study Type

Observational

Enrollment (Anticipated)

200

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, 75015
    - Recruiting
    - Assistance Publique - Hôpitaux de Paris
    - Contact:
      
      Jean-Luc Diehl, MD
      
      Phone Number: 0033156093201
      
      Email: jean-luc.diehl@aphp.fr
    - Contact:
      
      Nadia Aissaoui, MD
      
      Phone Number: 0033156093201
      
      Email: nadia.aissaoui@aphp.fr

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

3 types of patients : Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure at high risk to failed noninvasive ventilation Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) needing invasive ventilation in order to reduce mechanical ventilation duration Patients with ARDS and with the ail to reduce ventilation

Description

Inclusion Criteria:

Patients implanted with ECCCO2R

Exclusion Criteria:

Contra-indication to ECCO2R

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

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ECCO2R use Time Frame: Recorded monthly up to 100 weeks (24 months)	Number of ECCO2R implantation monthly by center	Recorded monthly up to 100 weeks (24 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality Time Frame: Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks	Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
Duration of mechanical ventilation Time Frame: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks	Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
ICU duration Time Frame: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks	Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
Ventilation modalities at discharge Time Frame: Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks	Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
hemorragic and thrombotic complications Time Frame: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks	Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
hemolysis Time Frame: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks	Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks

Collaborators and Investigators

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

Sponsor

Rexecor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Augy JL, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche JD, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl JL. A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area. J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.

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

January 1, 2016

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 11, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

APHP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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.