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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 : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Witten/Herdecke

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 (20-22Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-2 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 : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized-controlled Trial of Extracorporeal CO2 Removal (ECCO2R) to Facilitate Early Extubation Compared to Invasive Mechanical Ventilation in Patients With Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : July 1, 2023

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 (20-22Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-2 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. 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.


Secondary Outcome Measures :
  1. 1-year mortality or severe disability [ Time Frame: 1 year ]
    Change in mortality/severe disability rate

  2. Pneumonia during ICU treatment [ Time Frame: up to 60 days ]
    Change in Pneumonia rate

  3. 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

  4. Quality of life at 60 and 360 days (EQ-5D) [ Time Frame: 60 days and 360 days ]
    Change in Quality of life index

  5. Mobility, measured with ActiGraph [ Time Frame: up to 60 days ]
    Change in activity per day

  6. Treatment costs [ Time Frame: up to 60 days ]
    Change in absolute treatment costs

  7. Length of hospital stay [ Time Frame: up to 60 days ]
    Change in days of hospital stay

  8. Need for tracheostomy [ Time Frame: up to 60 days ]
    Change in rate of tracheostomy

  9. Reintubation rate [ Time Frame: up to 60 days ]
    Change in Reintubation rate



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute exacerbation of COPD requiring invasive mechanical ventilation
  • Known history of COPD
  • Acute and potentially reversible cause of acute respiratory failure as determined by the treating physician

Exclusion Criteria:

  • Intubated and mechanically ventilated for more than 7 days up to randomization
  • COPD exacerbations requiring invasive mechanical ventilation for more than 7 days within the last 12 months
  • ratio of arterial oxygen partial pressure to fractional inspired oxygen <120 mmHg
  • Age <18 years or >75 years
  • Contraindication for Heparin anticoagulation (aPTT 1.5-2x of normal range)
  • Severe chronic liver disease (Child Pugh>11)
  • End-stage medical condition other than COPD
  • Acute pulmonary embolism requiring lysis therapy

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: Christian Karagiannidis, M.D., Prof. +49/221-8907-18809 christian.karagiannidis@uni-wh.de
Contact: Anne Hage-Hülsmann Anne.hage-huelsmann@uni-wh.de

Sponsors and Collaborators
University of Witten/Herdecke
Investigators
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Principal Investigator: Christian Karagiannidis, M.D., Prof. University of Witten/Herdecke

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Responsible Party: University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT03584295     History of Changes
Other Study ID Numbers: ECCO2R2018
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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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