Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00852605
Status:
COMPLETED
Last Update Posted:
2009-02-27
First Post:
2009-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-26', 'studyFirstSubmitDate': '2009-02-26', 'studyFirstSubmitQcDate': '2009-02-26', 'lastUpdatePostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Acute Lung Injury after allogeneic transplantation'], 'conditions': ['Acute Lung Injury']}, 'descriptionModule': {'briefSummary': 'Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Recent data (Hilbert et al.) suggested a beneficial effect of Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons including stem-cell transplantation.\n\nThe investigators study is designed to evaluate early markers of ALI after allogeneic transplantation. In case ALI is documented patients are randomized to either conventional therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation. The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients undergoing allogeneic transplantation presenting with at least two of the following criteria\n\n* Respiratory rate \\>25 / min\n* Oxygenation Index \\<300\n* Continuous oxygen-saturation \\<92% whilst breathing room air\n\nExclusion Criteria:\n\n* Indication for Emergency intubation\n* Hemodynamic instability\n* Left ventricular failure\n* GCS \\<8\n* No consent'}, 'identificationModule': {'nctId': 'NCT00852605', 'briefTitle': 'Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation', 'orgStudyIdInfo': {'id': 'NIV2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Oxygen', 'description': 'Conventional Treatment including Oxygen-support'}, {'type': 'EXPERIMENTAL', 'label': 'NIV', 'description': 'Conventional Treatment plus intermittent Non-Invasive-Ventilation', 'interventionNames': ['Other: Intermittent Non-Invasive Ventilation']}], 'interventions': [{'name': 'Intermittent Non-Invasive Ventilation', 'type': 'OTHER', 'armGroupLabels': ['NIV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Illmer Thomas, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}}}}