Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-03-08 @ 12:55 PM
Study NCT ID:
NCT03584295
Status:
TERMINATED
Last Update Posted:
2025-03-14
First Post:
2018-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Extubation by ECCO2R Compared to IMV in Patients with Severe Acute Exacerbation of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or severe disability', 'timeFrame': 'day 60', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Mortality or severe disability at day 180 after randomization', 'timeFrame': 'Day 180', 'description': 'Change in mortality/severe disability rate'}, {'measure': 'Ventilator-associated pneumonia during ICU treatment', 'timeFrame': 'up to 60 days', 'description': '1. Some sign of respiratory distress, e.g., increased RR, increased FiO2\n2. New or enlarging infiltrates on CXR\n3. Culture of relevant organism from lung or major change in secretions from lung'}, {'measure': 'Reintubation rate', 'timeFrame': 'until day 180 after randomization', 'description': 'Number of reintubations'}, {'measure': 'Days on IMV or noninvasive ventilation (NIV) or ECCO2R', 'timeFrame': 'up to 60 days', 'description': 'defined as duration of total ventilatory support'}, {'measure': 'Thrombosis during treatment period', 'timeFrame': 'up to 29 Days', 'description': 'Thrombosis of major venous vessels during the treatment period'}, {'measure': 'Quality of life of patient', 'timeFrame': 'up to 180 days', 'description': 'Measured at day 60 and 180 after randomization, measured with Severe Respiratory Insufficiency and EQ-5D-5L Questionnaire'}, {'measure': 'Renal function', 'timeFrame': 'up to 29 days', 'description': 'Worsening of renal function'}, {'measure': 'Mobility, measured with ActiGraph', 'timeFrame': 'up to 180 days', 'description': 'Subgroup: Activity measurement with ActiGraph (at 1 centre)'}, {'measure': 'Treatment Cost', 'timeFrame': 'up to 180 days', 'description': 'Total Treatment costs for the hospital stay'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to 180 Days', 'description': 'Change in days of hospital stay'}, {'measure': 'Need of tracheostomy', 'timeFrame': 'Up to 180 Days', 'description': 'Change in rate of tracheostomy'}, {'measure': 'Breathing', 'timeFrame': 'up to 60 days', 'description': 'Breathing through tracheostomy at day 60 after randomization'}, {'measure': 'Readmission', 'timeFrame': 'Up to 180 Days', 'description': 'Readmission to hospital within 180 days after randomization'}, {'measure': 'Exacerbations', 'timeFrame': 'Up to 180 Days', 'description': 'Number of exacerbations within 180 days after randomization'}, {'measure': 'Severe Bleeding', 'timeFrame': 'up to 60 days', 'description': 'Defined as any bleeding event requiring administration of 1 unit of packed red cells, Detection of severe bleeding'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nAfter 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.\n\nConventional 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Informed consent signed and dated by the investigator; and\n\n 1. if patient is able to give consent: by the study patient\n 2. if patients unable to give consent: by the legal representative or\n 3. if an emergency situation is determined: by an independent consultant physician.\n2. Minimum age of 18 years\n3. In case of female patients:\n\n 1. Postmenopausal status defined as I. Prior bilateral oophorectomy Or II. Age ≥60 years Or if Age is \\<60 years or cannot be determined\n 2. A negative pregnancy test, defined as negative beta hCG test with a hCG level \\<5 mIU/mL.\n4. Known History of COPD\n5. Acute exacerbation of COPD requiring invasive mechanical ventilation\n6. Failed extubation attempt or extubation not possible within 24 hours after intubation\n7. Acute and potentially reversible cause of respiratory failure as determined by the treating physician\n\nExclusion Criteria:\n\n1. Any conditions which could interfere with the patient's ability to comply with the study\n2. In case of female patients: pregnancy and lactation period\n3. Participation in any interventional clinical study during the preceding 30 days\n4. Platelets \\<70.000/µl at baseline\n5. Previous participation in the X-COPD study\n6. Endotracheally intubated and mechanically ventilated for \\>96 hours prior to randomization\n7. 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)\n8. PaO2/FiO2 ratio \\<120 mmHg measured with FiO2 of 1.0\n9. Expectation of disease progression leading to high-flow extracorporeal membrane oxygenation (ECMO) treatment\n10. Cerebral haemorrhage\n11. Tracheostomy\n12. Estimated life expectancy \\<6 months due to reasons other than COPD\n13. Acute ischemic stroke\n14. Contraindication to anticoagulation\n15. Severe chronic liver disease (Child Pugh C)\n16. Acute pulmonary embolism requiring thrombolytic therapy\n17. Acute or chronic heart failure with left ventricular ejection fraction \\<30%\n18. Acute or chronic renal failure requiring dialysis\n19. Organ transplantation or immunosuppression due to ongoing immunosuppressive medication or neutropenia for instance following organ transplantation or anticancer therapy\n20. Neuromuscular disorder or chronic restrictive lung disease affecting native lung ventilation\n21. Known Heparin induced thrombocytopenia type II\n22. Acute coronary syndrome and myocardial infarction\n23. Obesity hypoventilation syndrome\n24. BMI \\>40\n25. Patient not expected to survive 48 hours\n26. Do not resuscitate (DNR) order"}, 'identificationModule': {'nctId': 'NCT03584295', 'acronym': 'X-COPD', 'briefTitle': 'Early Extubation by ECCO2R Compared to IMV in Patients with Severe Acute Exacerbation of COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'COPD-ECCO2R-01-INT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional care', 'description': '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.', 'interventionNames': ['Other: Conventional Care']}, {'type': 'EXPERIMENTAL', 'label': 'Extracorporeal carbon dioxide removal', 'description': '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.', 'interventionNames': ['Device: Extracorporeal carbon dioxide removal']}], 'interventions': [{'name': 'Extracorporeal carbon dioxide removal', 'type': 'DEVICE', 'description': 'Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation', 'armGroupLabels': ['Extracorporeal carbon dioxide removal']}, {'name': 'Conventional Care', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Conventional care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51109', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Christian Karagiannidis, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenios AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Winicker Norimed GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}