Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-19 @ 4:42 AM
Study NCT ID:
NCT05640635
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammation During ECMO Therapy and ECMO Weaning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6 concentration (blood samples)', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Daily control of above mentioned parameter.'}], 'secondaryOutcomes': [{'measure': 'SOFA-Score', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..', 'description': 'Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.'}, {'measure': 'Ventilation pressures', 'timeFrame': 'For the duration of the artificial ventilation, or a maximum of 60 days.', 'description': 'Pressures applied to the lung during artificial ventilation'}, {'measure': 'Murray Lung Injury Score (LIS)', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Assessement of severity of lung damage by the established Lung Injury Score by Murray (Min Value is 0, healthy and Max Value is 20, severly diseased)'}, {'measure': 'Length of stay in the intensive care unit', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Length of stay in the intensive care unit.'}, {'measure': 'Ventilator-associated pneumonia', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Occurence/incidence of ventilator-associated pneumonia.'}, {'measure': 'Cytokines and inflammatory cells in blood samples (IL-1beta, Il-10 and TNF-alpha)', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Collection of blood samples at various times points for further analysis.'}, {'measure': 'Cytokines and inflammatory cells in bronchoalveolar lavage (IL-1beta, Il-10 and TNF-alpha)', 'timeFrame': 'For the duration of the ICU stay, or a maximum of 60 days.', 'description': 'Collection of bronchoalveolar lavage samples at various times points for further analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress Syndrome', 'Extracorporal membrane oxygenation', 'Extracorporal membrane oxygenation weaning', 'Ventilation therapy'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional clinical trial is to compare patients who undergo ECMO therapy for treatment of acute respiratory distress syndrome (ARDS) and a randomized into one of two possible weaning strategy groups.\n\nGroup 1: Weaning from ventilator occurs before ECMO weaning.\n\nGroup 2: Weaning from ECMO occurs before weaning from ventilator.\n\nThis study investigates which one of these strategies is more indulgent for the lung, and leads to less inflammation and therefore less potential side effects and an overall more favourable clinical course.\n\nAs a primary criterion, measure of IL-6 in blood samples will beused. As secondary criterions, SOFA score at various time points, ventilation pressures, lung injury score (LIS), length of stay in the intensive care unit, and ventilator-associated pneumonia as well as levels of inflammatory cells and cytokines in both blood samples and bronchoalveolar lavage at different time points will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute respiratory distress syndrome (ARDS) according to the Berlin Definition (PaO2/FiO2 \\< 100) and treatment with veno-venous ECMO (vvECMO)\n* Hemodynamic stability\n* Lung compliance did not change/improved during the last 24 hours\n* Tidal volume did not change/improved during the last 24 hours with a PEEP of 10 cmH20 or above\n* Consent of the patient or their legal representative\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Artificial ventilation for more than 7 days prior\n* Patient, legal representative or doctors decided against an unrestricted intensive care treatment\n* Positive pregnancy test at time of screening\n* Cardiac failure requiring veno-arterial ECMO therapy\n* Chronic respiratory insufficiency requiring long-term oxygen treatment'}, 'identificationModule': {'nctId': 'NCT05640635', 'acronym': 'ECMOWean', 'briefTitle': 'Inflammation During ECMO Therapy and ECMO Weaning', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Inflammation During ECMO Therapy and ECMO Weaning', 'orgStudyIdInfo': {'id': 'ECMOWean'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ventilator weaning first', 'interventionNames': ['Procedure: Ventilator weaning first']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ECMO weaning first', 'interventionNames': ['Procedure: ECMO weaning first']}], 'interventions': [{'name': 'Ventilator weaning first', 'type': 'PROCEDURE', 'description': 'Ventilator weaning initiated and completed before start of ECMO weaning.', 'armGroupLabels': ['Ventilator weaning first']}, {'name': 'ECMO weaning first', 'type': 'PROCEDURE', 'description': 'ECMO weaning initiated and completed before start of ventilator weaning.', 'armGroupLabels': ['ECMO weaning first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Rosenberger, Prof. Dr.', 'role': 'CONTACT', 'email': 'peter.rosenberger@med.uni-tuebingen.de'}, {'name': 'Alice Bernard, Dr.', 'role': 'CONTACT', 'email': 'alice.bernard@med.uni-tuebingen.de'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Peter Rosenberger, Prof.', 'role': 'CONTACT', 'email': 'peter.rosenberger@med.uni-tuebingen.de', 'phone': '+49707129', 'phoneExt': '86622'}], 'overallOfficials': [{'name': 'Peter Rosenberger, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}