Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-12 @ 9:58 AM
Study NCT ID:
NCT02961166
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2016-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060166', 'term': 'pentaglobulin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-20', 'studyFirstSubmitDate': '2016-05-08', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'during ICU treatment, up to 28 days', 'description': 'Death during ICU therapy'}], 'secondaryOutcomes': [{'measure': 'lengh of stay (LOS ICU)', 'timeFrame': 'up to 60 days', 'description': 'lengh of stay on ICU in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVIG', 'ARDS', 'ECMO'], 'conditions': ['Respiratory Distress Syndrome, Adult', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '29497534', 'type': 'DERIVED', 'citation': 'Prohaska S, Schirner A, Bashota A, Korner A, Blumenstock G, Haeberle HA. Intravenous immunoglobulin fails to improve ARDS in patients undergoing ECMO therapy. J Intensive Care. 2018 Feb 26;6:11. doi: 10.1186/s40560-018-0278-8. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.\n\nThese patients were analyzed regarding length of stay in intensive care unit (LOS ICU), length of stay (LOS) in hospital and regarding mortality.', 'detailedDescription': '57 patients with ARDS requiring ECMO therapy were analyzed retrospectively. 28 patients had received IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.\n\nPatient characteristics, like Acute Physiology And Chronic Health Evaluation (APACHE) and Sepsis-related organ failure assessment (SAPS) Score, preexisting diseases, origin of infection, duration of ECMO therapy were analyzed in these patients.\n\nThese patients were further analyzed regarding LOS ICU, LOS in hospital and regarding mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ARDS patients treated by ECMO in the anesthesiological ICU of University Hospital Tuebingen between january 2012 and december 2015', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All data available\n* ARDS with ECMO therapy\n\nExclusion Criteria:\n\n* Data missing'}, 'identificationModule': {'nctId': 'NCT02961166', 'acronym': 'IVIG', 'briefTitle': 'Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Intravenous Immunoglobulin Therapy in ARDS Patients With Extracorporeal Membrane Oxygenation (ECMO) Therapy', 'orgStudyIdInfo': {'id': 'University Hospital Tuebingen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IgM enriched Immunoglobulins', 'description': 'ARDS patients with septic shock requiring ECMO therapy were treated for 3 days by IgM-enriched Immunoglobulin', 'interventionNames': ['Drug: IgM enriched Immunoglobulins']}, {'label': 'Control', 'description': 'ARDS patients with septic shock requiring ECMO therapy were NOT treated by IgM-enriched Immunoglobulin'}], 'interventions': [{'name': 'IgM enriched Immunoglobulins', 'type': 'DRUG', 'otherNames': ['Pentaglobin, Biotest Pharma GmbH Germany; Code 170a/90'], 'description': 'Treatment for 3 days', 'armGroupLabels': ['IgM enriched Immunoglobulins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Helene A Haeberle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universität Tübingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Helene Haeberle', 'investigatorFullName': 'PD Dr. Helene Haeberle', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}