Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-02 @ 10:07 AM
Study NCT ID:
NCT02189993
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'Up to 1427 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mortality', 'Long term follow-up', 'Parenteral Nutrition, Total'], 'conditions': ['Nutrition Disorders']}, 'referencesModule': {'references': [{'pmid': '25240075', 'type': 'DERIVED', 'citation': 'Oterdoom LH, Ten Dam SM, de Groot SD, Arjaans W, van Bodegraven AA. Limited long-term survival after in-hospital intestinal failure requiring total parenteral nutrition. Am J Clin Nutr. 2014 Oct;100(4):1102-7. doi: 10.3945/ajcn.114.087015. Epub 2014 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure.\n\nEarlier studies only followed patients for a maximum of 6 months or included only very specific patients. We were interested in all patients in our hospital and followed them for up to 2 years.', 'detailedDescription': 'Extensive description is not desired'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring total parenteral nutrition during in hospital admission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive patients on TPN\n\nExclusion Criteria:\n\n* patients from the Pediatric and Haematological Departments'}, 'identificationModule': {'nctId': 'NCT02189993', 'briefTitle': 'Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition', 'orgStudyIdInfo': {'id': 'TPN-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Parenteral Nutrition Use', 'description': 'The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Department of Gastroenterology and Hepatology, Small Bowel Unit, VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Leendert Oterdoom, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Leendert Oterdoom', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}