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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.


Clinical Trial 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


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

NCT number NCT02965079
Study type Observational
Source Rexecor
Contact Jean-Luc Diehl, MD
Phone 0033156093201
Email jean-luc.diehl@aphp.fr
Status Recruiting
Phase
Start date January 2016
Completion date June 2022