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

Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

— REXECOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965079
• Other study ID #: APHP
• Status: Recruiting
• Start date: January 2016
• Est. completion date: June 2022

Study information

• Verified date: September 2020
• Source: Rexecor
• Contact: Jean-Luc Diehl, MD
• Phone: 0033156093201
• Email: jean-luc.diehl[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. to assess efficacy and safety of ECCO2R,

2. to compare the data issue from the registry to others studies assessing the same population and to other centers and

3. to compare the different ECCOR devices in terms of efficacy and adverse events.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients implanted with ECCCO2R

Exclusion Criteria:

• Contra-indication to ECCO2R

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Diseases, Obstructive
• Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Patients With Acute Respiratory Distress Syndrome
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• ECCO2R
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

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Rexecor

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ECCO2R use	Number of ECCO2R implantation monthly by center	Recorded monthly up to 100 weeks (24 months)
Secondary	ICU mortality		Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
Secondary	Duration of mechanical ventilation		Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
Secondary	ICU duration		Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
Secondary	Ventilation modalities at discharge		Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
Secondary	hemorragic and thrombotic complications		Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
Secondary	hemolysis		Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks