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

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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 )

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: Extracorporeal carbon dioxide removal Other: Conventional Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mortality or severe disability at day 180 after randomization [ Time Frame: Day 180 ]
    Change in mortality/severe disability rate

  2. 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

  3. Reintubation rate [ Time Frame: until day 180 after randomization ]
    Number of reintubations

  4. Days on IMV or noninvasive ventilation (NIV) or ECCO2R [ Time Frame: up to 60 days ]
    defined as duration of total ventilatory support

  5. Thrombosis during treatment period [ Time Frame: up to 29 Days ]
    Thrombosis of major venous vessels during the treatment period

  6. 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

  7. Renal function [ Time Frame: up to 29 days ]
    Worsening of renal function

  8. Mobility, measured with ActiGraph [ Time Frame: up to 180 days ]
    Subgroup: Activity measurement with ActiGraph (at 1 centre)

  9. Treatment Cost [ Time Frame: up to 180 days ]
    Total Treatment costs for the hospital stay

  10. Length of hospital stay [ Time Frame: Up to 180 Days ]
    Change in days of hospital stay

  11. Need of tracheostomy [ Time Frame: Up to 180 Days ]
    Change in rate of tracheostomy

  12. Breathing [ Time Frame: up to 60 days ]
    Breathing through tracheostomy at day 60 after randomization

  13. Readmission [ Time Frame: Up to 180 Days ]
    Readmission to hospital within 180 days after randomization

  14. Exacerbations [ Time Frame: Up to 180 Days ]
    Number of exacerbations within 180 days after randomization

  15. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584295


Contacts
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Contact: Anja Derlet-Savoia, Dr +49 6172 608 2801 Anja.Derlet@fmc-ag.com

Sponsors and Collaborators
Xenios AG
Investigators
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Principal Investigator: Christian Karagiannidis, M.D, Prof. Dr. University of Witten/Herdecke
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Responsible Party: Xenios AG
ClinicalTrials.gov Identifier: NCT03584295    
Other Study ID Numbers: COPD-ECCO2R-01-INT
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022

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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