## Protocol Section
### Identification Module
**NCT ID:** NCT02965079

**Acronym:** REXECOR

**Brief Title:** 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

#### Organization Study ID Info
**ID:** APHP
#### Organization
**Class:** OTHER
**Full Name:** Rexecor
### Status Module
#### Completion Date
**Date:** 2022-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-10-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-10-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-01

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2016-11-16
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-09
**Study First Submit QC Date:** 2016-11-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Rexecor

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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

**Name:** ECCO2R

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of ECCO2R implantation monthly by center

**Measure:** Incidence of ECCO2R use

**Time Frame:** Recorded monthly up to 100 weeks (24 months)

#### Secondary Outcomes

**Measure:** ICU mortality

**Time Frame:** Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks

**Measure:** Duration of mechanical ventilation

**Time Frame:** Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks

**Measure:** ICU duration

**Time Frame:** Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks

**Measure:** Ventilation modalities at discharge

**Time Frame:** Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks

**Measure:** hemorragic and thrombotic complications

**Time Frame:** Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks

**Measure:** hemolysis

**Time Frame:** Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients implanted with ECCCO2R

Exclusion Criteria:

* Contra-indication to ECCO2R

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jean-luc.diehl@aphp.fr

**Name:** Jean-Luc Diehl, MD

**Phone:** 0033156093201

**Role:** CONTACT

**Contact 2:**

**Email:** nadia.aissaoui@aphp.fr

**Name:** Nadia Aissaoui, MD

**Phone:** 0033156093201

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** jean-luc.diehl@aphp.fr

- **Name:** Jean-Luc Diehl, MD

- **Phone:** 0033156093201

- **Role:** CONTACT

***Contact 2:***

- **Email:** nadia.aissaoui@aphp.fr

- **Name:** Nadia Aissaoui, MD

- **Phone:** 0033156093201

- **Role:** CONTACT

**Country:** France

**Facility:** Assistance Publique - Hopitaux de Paris

**Status:** RECRUITING

**Zip:** 75015

### References Module

#### 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.

**PMID:** 31452899

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000055370

- Term: Lung Injury

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M28144

- Name: Acute Lung Injury

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: M28143

- Name: Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

- ID: D000055371

- Term: Acute Lung Injury

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
