Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT01814956
Status:
TERMINATED
Last Update Posted:
2016-07-20
First Post:
2013-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Lipid Emulsions in Acute Lung Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2013-03-18', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in blood oxygenation (PaO2/FiO2ratio)', 'timeFrame': 'change day 1 to day 6'}], 'secondaryOutcomes': [{'measure': 'Triglycerides', 'timeFrame': 'day 1 to day 16'}, {'measure': 'Sequential Organ Failure Assessment', 'timeFrame': 'day 1 to day 28'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration\n* Oxygenation factor ≤ 300\n* \\<= 72 hours since intubation or non-invasive ventilatory support by mask at screening\n* Expected need for parenteral nutrition for at least 5 days\n* Male or female ≥ 18 years of age\n\nExclusion:\n\n* Exclusion of pregnancy in women with child-bearing potential\n* Cardiogenic pulmonary oedema\n* Previous (\\< 1 month) or ongoing need for corticosteroids \\>0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment\n* Active or previous (\\< 1 year) treatment for solid or haematologic malignancy\n* Serum triglycerides \\> 300 mg/dl at screening\n* Alterations of coagulation (thrombocytes \\<100 Giga/l), aPTT \\> 60 sec, INR ≥ 2.5 without therapeutic intervention\n* Autoimmune disease or HIV (according to medical history)\n* Known or suspected drug abuse\n* General contraindications to infusion therapy :'}, 'identificationModule': {'nctId': 'NCT01814956', 'briefTitle': 'Different Lipid Emulsions in Acute Lung Injury Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Prospective, Randomized, Controlled, Double-blind, Parallel-group, Mono-center, Explorative Phase IV Trial on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion Versus a Standard Soybean-oil Based Lipid Emulsion in Patients With Acute Lung Injury', 'orgStudyIdInfo': {'id': 'HC-G-H-0813'}, 'secondaryIdInfos': [{'id': '2011-003397-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'i.v. lipid emulsion for parenteral nutrition', 'interventionNames': ['Drug: Lipoplus 20%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'i.v. lipid emulsion for parenteral nutrition', 'interventionNames': ['Drug: Lipofundin N 20%']}], 'interventions': [{'name': 'Lipoplus 20%', 'type': 'DRUG', 'description': 'Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition', 'armGroupLabels': ['1']}, {'name': 'Lipofundin N 20%', 'type': 'DRUG', 'description': 'Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University Clinic Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}