Early Extubation by ECCO2R Compared to IMV in Patients with Severe Acute Exacerbation of COPD

NCT03584295 | Terminated DMC

• 1 other identifier: COPD-ECCO2R-01-INT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate if veno-venous (vv)-extracorporeal carbon dioxide Removal (ECCO2R) is capable of reducing mortality and/or severe disability at day 60 after randomisation in patients with severe acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation (IMV). Extubation will be facilitated by VV-ECCO2R and compared to IMV alone in a randomized controlled trial.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Death or severe disability

  Death or severe disability at day 60 after randomization, with severe disability defined as confinement to bed and/or inability to wash or dress alone and/or need for long-term invasive mechanical ventilation by day 60

  day 60

Secondary Outcomes (15)

• Mortality or severe disability at day 180 after randomization

  Day 180

• Ventilator-associated pneumonia during ICU treatment

  up to 60 days

• Reintubation rate

  until day 180 after randomization

• Days on IMV or noninvasive ventilation (NIV) or ECCO2R

  up to 60 days

• Thrombosis during treatment period

  up to 29 Days

Study Arms (2)

Conventional care

ACTIVE COMPARATOR

Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.

Other: Conventional Care

Extracorporeal carbon dioxide removal

EXPERIMENTAL

Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R (Extracorporeal carbon dioxide removal) to facilitate early extubation. ECCO2R is used in a standard configuration with either double lumen cannula (22-24Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-1.75 L/min.

Device: Extracorporeal carbon dioxide removal

Interventions

Extracorporeal carbon dioxide removal DEVICE

Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation

Extracorporeal carbon dioxide removal

Conventional Care OTHER

Patient with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional Care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.

Conventional care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed and dated by the investigator; and
• if patient is able to give consent: by the study patient
• if patients unable to give consent: by the legal representative or
• if an emergency situation is determined: by an independent consultant physician.
• Minimum age of 18 years
• In case of female patients:
• Postmenopausal status defined as I. Prior bilateral oophorectomy Or II. Age ≥60 years Or if Age is \<60 years or cannot be determined
• A negative pregnancy test, defined as negative beta hCG test with a hCG level \<5 mIU/mL.
• Known History of COPD
• Acute exacerbation of COPD requiring invasive mechanical ventilation
• Failed extubation attempt or extubation not possible within 24 hours after intubation
• Acute and potentially reversible cause of respiratory failure as determined by the treating physician

You may not qualify if:

• Any conditions which could interfere with the patient's ability to comply with the study
• In case of female patients: pregnancy and lactation period
• Participation in any interventional clinical study during the preceding 30 days
• Platelets \<70.000/µl at baseline
• Previous participation in the X-COPD study
• Endotracheally intubated and mechanically ventilated for \>96 hours prior to randomization
• Acute liver failure, defined by an international normalized ratio (INR) \>2 without anticoagulation and/or bilirubin \>4 mg/dL (\>68 μmol/L) and/or hepatic encephalopathy (all three apply)
• PaO2/FiO2 ratio \<120 mmHg measured with FiO2 of 1.0
• Expectation of disease progression leading to high-flow extracorporeal membrane oxygenation (ECMO) treatment
• Cerebral haemorrhage
• Tracheostomy
• Estimated life expectancy \<6 months due to reasons other than COPD
• Acute ischemic stroke
• Contraindication to anticoagulation
• Severe chronic liver disease (Child Pugh C)

Sponsors & Collaborators

• Xenios AG: lead
• Winicker Norimed GmbH: collaborator

Study Sites (1)

Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim

Cologne, 51109, Germany

Location

Study Officials

• Christian Karagiannidis, Prof. Dr.

  Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 12, 2018
• Study Start: February 7, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 25, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)