Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04347902
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lipid Emulsions and Liver Function - Results After 5 Years.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005217', 'term': 'Fat Emulsions, Intravenous'}], 'ancestors': [{'id': 'D004655', 'term': 'Emulsions'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D057947', 'term': 'Parenteral Nutrition Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver disfunction', 'timeFrame': '5 years', 'description': 'Liver tests results during parenteral nutrition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Failure', 'Parenteral Nutrition-Related Hepatitis']}, 'referencesModule': {'references': [{'pmid': '29960156', 'type': 'RESULT', 'citation': 'Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). The aim of the study was to analyse the influence of ILEs on liver function during long term PN.', 'detailedDescription': 'Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). Despite of many commercially available ILEs with hypothetically different impact on liver, a direct comparison of them has never been performed. Therefore the aim of the study was to analyse the influence of ILEs on liver function during long term PN. Ths study is a continuation of the previous trial, NCT03044639.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age,\n* chronic intestinal failure on PN including lipids,\n* metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)\n* ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN\n\nExclusion Criteria:\n\n* preexisting liver dysfunction (an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 3 times x normal value),\n* patients with a history of cancer and anti-cancer treatment within the last 5 years,\n* severe hyperlipidemia,\n* severe coagulopathy,\n* severe renal insufficiency,\n* acute thromboembolic events,\n* positive test for HIV, Hepatitis B or C (from medical history),\n* known or suspected drug or alcohol abuse,\n* participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial,\n* for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.'}, 'identificationModule': {'nctId': 'NCT04347902', 'acronym': '5ylipids', 'briefTitle': 'Lipid Emulsions and Liver Function - Results After 5 Years.', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.', 'orgStudyIdInfo': {'id': 'Lipids-5 year'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PN with SMOFLipid', 'description': 'Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)', 'interventionNames': ['Drug: Intravenous Lipid Emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PN with Olive oil', 'description': 'Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)', 'interventionNames': ['Drug: Intravenous Lipid Emulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PN with MCT/LCT', 'description': 'Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)', 'interventionNames': ['Drug: Intravenous Lipid Emulsion']}], 'interventions': [{'name': 'Intravenous Lipid Emulsion', 'type': 'DRUG', 'description': 'Various types of intravenous lipids', 'armGroupLabels': ['PN with MCT/LCT', 'PN with Olive oil', 'PN with SMOFLipid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-050', 'city': 'Skawina', 'country': 'Poland', 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}], 'overallOfficials': [{'name': 'Stanislaw Klek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stanley Dudrick's Memorial Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the General Surgery Unit', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}