Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00142220
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-08', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of IL-6 in serum'}, {'measure': 'HLA-expression on monocytes'}], 'secondaryOutcomes': [{'measure': 'number of nosocomial infections'}, {'measure': 'days on mechanical ventilation'}, {'measure': 'duration of ICU stay'}, {'measure': 'mortality'}, {'measure': 'SOFA score'}]}, 'conditionsModule': {'conditions': ['Sepsis Syndrome']}, 'descriptionModule': {'briefSummary': 'We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in the nutrition of critically ill patients reduces systemic inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for parenteral nutrition\n\nExclusion Criteria:\n\n* hypertriglyceridemia\n* coagulation disorder\n* decompensated liver cirrhosis or acute liver failure'}, 'identificationModule': {'nctId': 'NCT00142220', 'briefTitle': 'The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Comparison Between Two Different Proportions of Omega-3- and Omega-6-Fatty Acids in the Parenteral Nutrition of Critically Ill Patients', 'orgStudyIdInfo': {'id': 'OMEGAVEN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Defined percentage of omega-3-fatty acids', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Internistische ITS', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Sigrun Friesecke, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius AG', 'class': 'INDUSTRY'}]}}}