Patients With Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseREXECORNCT02965079
Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
An observational study of Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Patients With Acute Respiratory Distress Syndrome, run by Rexecor at 1 site in France.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Patients With Acute Respiratory Distress Syndrome
- What is being tested?
- ECCO2R
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients implanted with ECCCO2R
Who cannot join
- Contra-indication to ECCO2R
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hopitaux de Paris
Paris, 75015
Jean-Luc Diehl, MD, 0033156093201, jean-luc.diehl@aphp.fr
Nadia Aissaoui, MD, 0033156093201, nadia.aissaoui@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Patients With Acute Respiratory Distress Syndrome
- Being tested
- ECCO2R
- Keywords
- extracorporeal CO2 removal, registry, COPD and ARDS, CEDIT on behalf of APHP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCO2RDevice
The ECCO2R system was developed from the principle of ECMO systems by underscoring the importance of carbon dioxide elimination rather than direct improvement of oxygenation in some patients. The circuit of the ECCO2R system can be set up in venovenous (VV) or arteriovenous (AV). For VV setup, a low flow pump is used to maintain a low extracorporeal flow rate using only 20-30 % of cardiac output. The ECCO2R system does not provide complete pulmonary function as it can achieve only limited oxygenation but provides predominantly carbon dioxide removal. As neither VV nor AV circuit allows full cardiopulmonary bypass, the system provides respiratory function but no cardiac support
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ECCO2R use
Number of ECCO2R implantation monthly by center
Measured: Recorded monthly up to 100 weeks (24 months)
Secondary outcomes (6)
ICU mortality
Measured: Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
Duration of mechanical ventilation
Measured: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
ICU duration
Measured: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
Ventilation modalities at discharge
Measured: Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
hemorragic and thrombotic complications
Measured: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
hemolysis
Measured: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rexecor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965079
- Sponsor's protocol ID
- APHP
- Acronym
- REXECOR
- Status last verified
- Sep 2020
- First submitted
- 9 Nov 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31452899
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
- ClinicalTrials.gov ID
- NCT02965079
- Acronym / sponsor ID
- REXECOR / APHP
- Conditions
- Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Patients With Acute Respiratory Distress Syndrome
- Keywords
- extracorporeal CO2 removal, registry, COPD and ARDS, CEDIT on behalf of APHP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RexecorUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients implanted with ECCCO2R
Key exclusion criteria (1 listed)
- Contra-indication to ECCO2R
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECCO2RThe ECCO2R system was developed from the principle of ECMO systems by underscoring the importance of carbon dioxide elimination rather than direct improvement of oxygenation in some patients. The circuit of the ECCO2R system can be set up in venovenous (VV) or arteriovenous (AV). For VV setup, a low flow pump is used to maintain a low extracorporeal flow rate using only 20-30 % of cardiac output. The ECCO2R system does not provide complete pulmonary function as it can achieve only limited oxygenation but provides predominantly carbon dioxide removal. As neither VV nor AV circuit allows full cardiopulmonary bypass, the system provides respiratory function but no cardiac support | Device | – |
Primary outcome
Incidence of ECCO2R use
Time frame: Recorded monthly up to 100 weeks (24 months)
Number of ECCO2R implantation monthly by center
6 secondary outcomes
ICU mortality
Time frame: 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
ICU duration
Time frame: 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
hemorragic and thrombotic complications
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Derived from this study: PubMed 31452899Augy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Patients With Acute Respiratory Distress Syndrome, run by Rexecor at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc Diehl, MD (0033156093201, jean-luc.diehl@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ECCO2R use (time frame: Recorded monthly up to 100 weeks (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.