Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT01176695
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2010-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate on the efficacy of fish oil on the nutrition status', 'timeFrame': 'day 1 to day 6', 'description': 'Prealbumin as the primary endpoint variable'}, {'measure': 'To investigate on the efficacy of fish oil on an inflammatory parameter', 'timeFrame': 'day 1 to day 6', 'description': 'LTB5/LTB4 as a second primary endpoint'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative complications', 'timeFrame': '6 days'}, {'measure': 'Liver function', 'timeFrame': '6 days'}, {'measure': 'Coagulation parameters', 'timeFrame': '6 days'}, {'measure': 'Blood chemistry', 'timeFrame': '6 days'}, {'measure': 'SIRS', 'timeFrame': '6 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery\n* Male and female patients ≥18 and \\<85 years of age\n* Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation\n* Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)\n* General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency\n* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients\n* Other'}, 'identificationModule': {'nctId': 'NCT01176695', 'briefTitle': 'Efficacy and Safety of a Fish Oil Containing Lipid Emulsion', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity', 'orgStudyIdInfo': {'id': 'HC-G-H-0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'fish oil containing lipid emulsion', 'interventionNames': ['Drug: fish oil containing lipid emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'MCT/LCT containing lipid emulsion', 'interventionNames': ['Drug: MCT/LCT containing lipid emulsion']}], 'interventions': [{'name': 'fish oil containing lipid emulsion', 'type': 'DRUG', 'description': 'medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides', 'armGroupLabels': ['1']}, {'name': 'MCT/LCT containing lipid emulsion', 'type': 'DRUG', 'description': 'medium chain triglycerides, long chain triglycerides', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Hospitals', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210002', 'city': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ning Li, Prof. MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}