Clinical trial NCT02965079: Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
Official title: Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Rexecor
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients implanted with ECCCO2R

Exclusion Criteria:

* Contra-indication to ECCO2R

Primary outcomes:
measure: Incidence of ECCO2R use
timeFrame: Recorded monthly up to 100 weeks (24 months)
Secondary outcomes:
measure: ICU mortality
timeFrame: Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
measure: Duration of mechanical ventilation
timeFrame: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
measure: ICU duration
timeFrame: Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
measure: Ventilation modalities at discharge
timeFrame: Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
measure: hemorragic and thrombotic complications
timeFrame: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
measure: hemolysis
timeFrame: Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris
Study officials:
References:
citation: 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.