A Multicentre, Randomized-controlled Trial of EXtracorporeal CO2 Removal to Facilitate Early Extubation Compared to Invasive Mechanical Ventilation in Patients with Severe Acute Exacerbation of COPD (X-COPD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD Exacerbation
- Sponsor
- Xenios AG
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Death or severe disability
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Death or severe disability
Time Frame: day 60
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
Secondary Outcomes
- Mortality or severe disability at day 180 after randomization(Day 180)
- Thrombosis during treatment period(up to 29 Days)
- Renal function(up to 29 days)
- Ventilator-associated pneumonia during ICU treatment(up to 60 days)
- Reintubation rate(until day 180 after randomization)
- Treatment Cost(up to 180 days)
- Length of hospital stay(Up to 180 Days)
- Severe Bleeding(up to 60 days)
- Quality of life of patient(up to 180 days)
- Breathing(up to 60 days)
- Exacerbations(Up to 180 Days)
- Days on IMV or noninvasive ventilation (NIV) or ECCO2R(up to 60 days)
- Mobility, measured with ActiGraph(up to 180 days)
- Need of tracheostomy(Up to 180 Days)
- Readmission(Up to 180 Days)