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Early Extubation by ECCO2R Compared to IMV in Patients With Severe Acute Exacerbation of COPD (X-COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584295
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH ( Xenios AG )

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date August 2, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
Death or severe disability [ Time Frame: day 60 ]
Death or severe disability at day 60 after randomization. Severe disability is defined as confinement to bed and/or inability to wash or dress alone and/or need for long-term invasive mechanical ventilation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • Mortality or severe disability at day 180 after randomization [ Time Frame: Day 180 ]
    Change in mortality/severe disability rate
  • Ventilator-associated pneumonia during ICU treatment [ Time Frame: up to 60 days ]
    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
  • Reintubation rate [ Time Frame: until day 180 after randomization ]
    Number of reintubations
  • Days on IMV or noninvasive ventilation (NIV) or ECCO2R [ Time Frame: up to 60 days ]
    defined as duration of total ventilatory support
  • Thrombosis during treatment period [ Time Frame: up to 29 Days ]
    Thrombosis of major venous vessels during the treatment period
  • Quality of life of patient [ Time Frame: up to 180 days ]
    Measured at day 60 and 180 after randomization, measured with Severe Respiratory Insufficiency and EQ-5D-5L Questionnaire
  • Renal function [ Time Frame: up to 29 days ]
    Worsening of renal function
  • Mobility, measured with ActiGraph [ Time Frame: up to 180 days ]
    Subgroup: Activity measurement with ActiGraph (at 1 centre)
  • Treatment Cost [ Time Frame: up to 180 days ]
    Total Treatment costs for the hospital stay
  • Length of hospital stay [ Time Frame: Up to 180 Days ]
    Change in days of hospital stay
  • Need of tracheostomy [ Time Frame: Up to 180 Days ]
    Change in rate of tracheostomy
  • Breathing [ Time Frame: up to 60 days ]
    Breathing through tracheostomy at day 60 after randomization
  • Readmission [ Time Frame: Up to 180 Days ]
    Readmission to hospital within 180 days after randomization
  • Exacerbations [ Time Frame: Up to 180 Days ]
    Number of exacerbations within 180 days after randomization
  • Severe Bleeding [ Time Frame: up to 60 days ]
    Defined as any bleeding event requiring administration of 1 unit of packed red cells, Detection of severe bleeding
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 1-year mortality or severe disability [ Time Frame: 1 year ]
    Change in mortality/severe disability rate
  • Pneumonia during ICU treatment [ Time Frame: up to 60 days ]
    Change in Pneumonia rate
  • Days on IMV/ Time on extracorporeal life support (=duration of support) [ Time Frame: up to 60 days ]
    Change in days on IMV/Time on extracorporeal life support
  • Quality of life at 60 and 360 days (EQ-5D) [ Time Frame: 60 days and 360 days ]
    Change in Quality of life index
  • Mobility, measured with ActiGraph [ Time Frame: up to 60 days ]
    Change in activity per day
  • Treatment costs [ Time Frame: up to 60 days ]
    Change in absolute treatment costs
  • Length of hospital stay [ Time Frame: up to 60 days ]
    Change in days of hospital stay
  • Need for tracheostomy [ Time Frame: up to 60 days ]
    Change in rate of tracheostomy
  • Reintubation rate [ Time Frame: up to 60 days ]
    Change in Reintubation rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Extubation by ECCO2R Compared to IMV in Patients With Severe Acute Exacerbation of COPD
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COPD Exacerbation
Intervention  ICMJE
  • 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
  • Other: Conventional Care
    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.
Study Arms  ICMJE
  • Active Comparator: Conventional care
    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.
    Intervention: Other: Conventional Care
  • Experimental: Extracorporeal carbon dioxide removal
    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.
    Intervention: Device: Extracorporeal carbon dioxide removal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2020)
192
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
202
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Informed consent signed and dated by the investigator; and

    1. if patient is able to give consent: by the study patient
    2. if patients unable to give consent: by the legal representative or
    3. if an emergency situation is determined: by an independent consultant physician.
  2. Minimum age of 18 years
  3. In case of female patients:

    1. Postmenopausal status defined as I. Prior bilateral oophorectomy Or II. Age ≥60 years Or if Age is <60 years or cannot be determined
    2. A negative pregnancy test, defined as negative beta hCG test with a hCG level <5 mIU/mL.
  4. Known History of COPD
  5. Acute exacerbation of COPD requiring invasive mechanical ventilation
  6. Failed extubation attempt or extubation not possible within 24 hours after intubation
  7. Acute and potentially reversible cause of respiratory failure as determined by the treating physician

Exclusion Criteria:

  1. Any conditions which could interfere with the patient's ability to comply with the study
  2. In case of female patients: pregnancy and lactation period
  3. Participation in any interventional clinical study during the preceding 30 days
  4. Platelets <70.000/µl at baseline
  5. Previous participation in the X-COPD study
  6. Endotracheally intubated and mechanically ventilated for >96 hours prior to randomization
  7. 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)
  8. PaO2/FiO2 ratio <120 mmHg measured with FiO2 of 1.0
  9. Expectation of disease progression leading to high-flow extracorporeal membrane oxygenation (ECMO) treatment
  10. Cerebral haemorrhage
  11. Tracheostomy
  12. Estimated life expectancy <6 months due to reasons other than COPD
  13. Acute ischemic stroke
  14. Contraindication to anticoagulation
  15. Severe chronic liver disease (Child Pugh C)
  16. Acute pulmonary embolism requiring thrombolytic therapy
  17. Acute or chronic heart failure with left ventricular ejection fraction <30%
  18. Acute or chronic renal failure requiring dialysis
  19. Organ transplantation or immunosuppression due to ongoing immunosuppressive medication or neutropenia for instance following organ transplantation or anticancer therapy
  20. Neuromuscular disorder or chronic restrictive lung disease affecting native lung ventilation
  21. Known Heparin induced thrombocytopenia type II
  22. Acute coronary syndrome and myocardial infarction
  23. Obesity hypoventilation syndrome
  24. BMI >40
  25. Patient not expected to survive 48 hours
  26. Do not resuscitate (DNR) order
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anja Derlet-Savoia, Dr +49 6172 608 2801 Anja.Derlet@fmc-ag.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584295
Other Study ID Numbers  ICMJE COPD-ECCO2R-01-INT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fresenius Medical Care Deutschland GmbH ( Xenios AG )
Original Responsible Party University of Witten/Herdecke
Current Study Sponsor  ICMJE Xenios AG
Original Study Sponsor  ICMJE University of Witten/Herdecke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Karagiannidis, M.D, Prof. Dr. University of Witten/Herdecke
PRS Account Fresenius Medical Care Deutschland GmbH
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP