An interventional study of Extracorporeal carbon dioxide removal and Conventional Care in COPD Exacerbation, sponsored by Xenios AG. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Xenios AG · Not applicable, Interventional, and Treatment
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.
The current study hypothesizes an advantage for veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) in severe acute exacerbation of COPD requiring invasive mechanical ventilation (IMV) to facilitate early extubation in terms of reducing mortality or severe disability. The study hypothesizes that avoiding IMV could reduce mortality and substantially improve quality of life, especially in regard to avoidance of tracheostomy and long-term home IMV. Improvement in mobility due to sooner recovery has a further major impact on patients' QoL.
After randomization patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated either with conventional care or VV-ECCO2R to facilitate early extubation. VV-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.
Conventional care in the control arm includes invasive mechanical ventilation and the attempt to extubate the patient as early as possible and to switch to non-invasive ventilation (NIV). If extubation fails, tracheostomy can be performed according to the discretion of the treating physician.
Xenios AG is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Informed consent signed and dated by the investigator; and
In case of female patients:
Exclusion Criteria:
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
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
Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation
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.
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
Time frame: day 60
Mortality or severe disability at day 180 after randomization
Change in mortality/severe disability rate
Time frame: Day 180
Ventilator-associated pneumonia during ICU treatment
1. Some sign of respiratory distress, e.g., increased RR, increased FiO2 2. New or enlarging infiltrates on CXR 3. Culture of relevant organism from lung or major change in secretions from lung
Time frame: up to 60 days
Reintubation rate
Number of reintubations
Time frame: until day 180 after randomization
Days on IMV or noninvasive ventilation (NIV) or ECCO2R
defined as duration of total ventilatory support
Time frame: up to 60 days
Thrombosis during treatment period
Thrombosis of major venous vessels during the treatment period
Time frame: up to 29 Days
Quality of life of patient
Measured at day 60 and 180 after randomization, measured with Severe Respiratory Insufficiency and EQ-5D-5L Questionnaire
Time frame: up to 180 days
Renal function
Worsening of renal function
Time frame: up to 29 days
Mobility, measured with ActiGraph
Subgroup: Activity measurement with ActiGraph (at 1 centre)
Time frame: up to 180 days
Treatment Cost
Total Treatment costs for the hospital stay
Time frame: up to 180 days
Length of hospital stay
Change in days of hospital stay
Time frame: Up to 180 Days
Need of tracheostomy
Change in rate of tracheostomy
Time frame: Up to 180 Days
Breathing
Breathing through tracheostomy at day 60 after randomization
Time frame: up to 60 days
Readmission
Readmission to hospital within 180 days after randomization
Time frame: Up to 180 Days
Exacerbations
Number of exacerbations within 180 days after randomization
Time frame: Up to 180 Days
Severe Bleeding
Defined as any bleeding event requiring administration of 1 unit of packed red cells, Detection of severe bleeding
Time frame: up to 60 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Xenios AG