Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01162161
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2010-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Sphingolipids in Pulmonary Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2010-07-13', 'studyFirstSubmitQcDate': '2010-07-13', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sphingolipid', 'ceramide', 'sphingomyelinase'], 'conditions': ['Pulmonary Edema']}, 'descriptionModule': {'briefSummary': 'In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.', 'detailedDescription': 'There will be three groups of patients:\n\n1. hydrostatic pulmonary edema\n2. toxic pulmonary edema\n3. not ventilated patients without any pulmonary edema\n\nSamples of a routine bronchoalveolar lavage and EDTA-blood will be analysed in respect of sphingolipids, ceramide, sphingomyelin-phosphodiesterase and several cytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3 groups\n\nfirst group: patients with a lung oedema because of a pneumonia (about 30 patients)\n\nsecond group: patients with a lung oedema because of cardiac insufficiency (about 25 patients)\n\nthird group: patients without any lung oedema (about 15 patients)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above the age of 18\n\nExclusion Criteria:\n\n* taking steroids'}, 'identificationModule': {'nctId': 'NCT01162161', 'acronym': '09-045', 'briefTitle': 'Role of Sphingolipids in Pulmonary Edema', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Role of Sphingolipids in Pulmonary Edema', 'orgStudyIdInfo': {'id': 'Sphingo-AC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hydrostatic pulmonary edema', 'description': 'patients with a pulmonary edema caused by chronic heart failure'}, {'label': 'toxic pulmonary edema', 'description': 'patients with a pulmonary edema preceded by pneumonia'}, {'label': 'control group', 'description': 'not ventilated patients without any pulmonary edema receiving a bronchoscopy due to another pulmonary problem (no pneumonia, no heart failure)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Medical Clinic I, University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Stefan Krüger, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}