Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-04 @ 12:40 PM
Study NCT ID:
NCT00538928
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2007-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-01', 'studyFirstSubmitDate': '2007-10-02', 'studyFirstSubmitQcDate': '2007-10-02', 'lastUpdatePostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator free days within 28 days after enrollment', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'hospital mortality, organ-failure free days, pulmonary gas exchange', 'timeFrame': '28 days - 60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute respiratory distress syndrome', 'extracorporeal lung support', 'hypoxia', 'hypercapnia', 'acute respiratory distress syndrome (ARDS)'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '16540950', 'type': 'BACKGROUND', 'citation': 'Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7. doi: 10.1097/01.CCM.0000215111.85483.BD.'}, {'pmid': '23306584', 'type': 'DERIVED', 'citation': "Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10."}]}, 'descriptionModule': {'briefSummary': 'A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist \\[iLA\\] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome \\[ARDS\\] with a PaO2/FiO2 ratio \\< 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.', 'detailedDescription': 'Evaluation group:\n\nImplantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.\n\nControl group:\n\nVentilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) \\< 200 mmHg. These parameters must be present for a duration of at least 2 hours.\n\nExclusion Criteria:\n\n* age \\< 18 years\n* decompensated heart insufficiency\n* acute coronary syndrome\n* severe chronic obstructive pulmonary disease\n* advanced tumour conditions with life expectancy \\< 6 months\n* chronic dialysis treatment\n* lung transplant patients\n* proven Heparin-induced thrombocytopenia (HIT)\n* morbid obesity (BMI \\>) 40\n* Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure\n* severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse\n* brain injury (GCS \\< 9 + CT pathology)'}, 'identificationModule': {'nctId': 'NCT00538928', 'acronym': 'Xtravent', 'briefTitle': 'Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study', 'orgStudyIdInfo': {'id': 'KKS 4012-001-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.', 'interventionNames': ['Other: lung protective ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).', 'interventionNames': ['Other: lung protective ventilation']}], 'interventions': [{'name': 'lung protective ventilation', 'type': 'OTHER', 'description': 'tidal volume 6 ml/kg ideal body weight', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93042', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Thomas Bein, Professor Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Regensburg'}, {'name': 'Steffen Weber-Carstens, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite University Hospital Berlin'}, {'name': 'Thomas Staudinger, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Vienna, Austria'}, {'name': 'Sven Bercker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Leipzig, Germany'}, {'name': 'Ralph Müllenbach, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Würzburg, Germany'}, {'name': 'Rolf Dembinski, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Aachen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Department of Anesthesia', 'oldOrganization': 'University Hospital'}}}}