Viewing Study NCT03239093


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Study NCT ID: NCT03239093
Status: COMPLETED
Last Update Posted: 2017-08-03
First Post: 2017-08-01
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Sixteen Years Trends in Reported Undernutrition in Switzerland
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13297188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay', 'timeFrame': '1998-2014', 'description': 'Overall length of hospital stay, in days'}, {'measure': 'In-hospital mortality', 'timeFrame': '1998-2014', 'description': 'Hospital mortality (code=deceased)'}, {'measure': 'Nosocomial infection', 'timeFrame': '1998-2014', 'description': 'ICD-10 codes T80.2 (Infections following infusion, transfusion and therapeutic injection); T82.6 (Infection and inflammatory reaction due to cardiac valve prosthesis); T82.7 (Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts); T83.5 (Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system); T83.6 (Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract); T84.5 (Infection and inflammatory reaction due to internal joint prosthesis); T84.6 (Infection and inflammatory reaction due to internal fixation device \\[any site\\]); T84.7 (Infection and inflammatory reaction due to other internal orthopaedic prosthetic devices, implants and grafts); T85.7 (Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts); A04.7 (Clostridium difficile infection);'}], 'primaryOutcomes': [{'measure': 'undernutrition reporting', 'timeFrame': '1998-2014', 'description': 'ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia).'}], 'secondaryOutcomes': [{'measure': 'nutritional management', 'timeFrame': '1998-2014', 'description': 'CHOP codes related to enteral nutrition (96.6 and 96.35), parenteral nutrition (99.15), nutritional advice and therapy (89.0A.30, 89.0A.31 or 89.0A.32, depending on year) and multimodal nutritional therapy (89.0A.4\\*, where \\*=any number).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Epidemiology']}, 'descriptionModule': {'briefSummary': 'To assess 16-year trends in undernutrition reporting and management in Switzerland', 'detailedDescription': 'Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it covers 98% of public and private hospitals within Switzerland and includes all stays for each hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalizations representing 98% of public and private hospitals within Switzerland', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (aged ≥20 years), length of hospital stay \\>1 day, not having any ICD-10 codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning with letter "O") as main diagnosis, and having complete demographic data and information on main diagnosis and mortality\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03239093', 'briefTitle': 'Sixteen Years Trends in Reported Undernutrition in Switzerland', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Sixteen Years Trends in Reported Undernutrition in Switzerland', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational study using official data from the Federal Office of Statistics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data request must be sent to the Swiss Federal Office of Statistics (http://www.bfs.admin.ch) and must comply with Swiss data protection rules'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Pedro Marques-Vidal', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}