Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05917418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018529', 'term': 'Nutritional Support'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2040-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2023-06-03', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Infectious complication', 'timeFrame': 'during the hospital stay', 'description': 'A infectious complication was defined as as the presence of recognized pathogens in body tissues that normally are sterile, confirmed by the results of culture and supported by clinical, radiologic or hematologic evidence of infection'}], 'secondaryOutcomes': [{'measure': 'Total cost amount', 'timeFrame': 'during the hospital stay', 'description': "The total cost amount was considered to contain 3 items in our study. The first item was the cost of nutrition support, including nutrition solutions, nursing, physician, and other staff supervision of nutrition support preparation, administration, and catheter placement and maintenance. The second item was the cost of the infectious complication.The third item was 'other costs' associated with the hospital admission, calculated from the total costs from which the cost of nutrition support and infectious complications were subtracted."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.', 'detailedDescription': "Although it was often to hear that malnutrition ratio in Aisa hospitalized patient was 40%-70% , there was no evidence to elaborate the prevalence of nutritional risk and malnutrition on hospitalized patients of Asia. Also in USA no data for nutritional risk. In 2002, scientists group headed by Kondrup from : European Society for Parenteral and Enteral Nutrition demonstrated that randomized controlled clinical trials showed patients may get benefit from nutrition support when they with nutrition risk. Based on these evidences, a simpler method was established by European Society for Parenteral and Enteral Nutrition in year 2002 in Munich \\& it was demonstrated useful to evaluate the appropriate use of nutrition support at present time. This method was named as Nutrition Risk Screening (NRS).\n\nInvestigators propose to survey the prevalence of malnutrition \\& nutrition risk in large cities' large/middle size hospitalized patients in China, Europe and USA use NRS tool. As well, we also aim to figure out the current nutrition support status in current large/middle size hospitals through this survey.\n\nInvestigators also propose to evaluate the cost-effectiveness of parenteral nutrition, enteral nutrition and non-nutritional support, and to examine the clinical outcomes of nutritional support in certain patients at nutritional risk identified by NRS-2002.\n\nFor international cooperation, the partners are Professor Kondrup of Europe and Professor Nolan from Johns Hopkins Hospital,there are students from a cooperative project with Johns Hopkins Hospital for Doctor of Philosophy students 2005-2011."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients be in hospital overnight\n* diagnoses according to the protocol of cohort study for cost effectiveness\n\nExclusion Criteria:\n\n* patients admitting from emergency department\n* patients who undergone operation before second morning of hospitalization\n* patients who dose not give Informed Consents'}, 'identificationModule': {'nctId': 'NCT05917418', 'briefTitle': 'Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Impact of Nutritional Support on Outcome,Cost/Effectiveness for Patient at Risk', 'orgStudyIdInfo': {'id': 'CMA2023CSPEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional support therapy group', 'description': 'All participants in this group will receive proper nutritional support.', 'interventionNames': ['Dietary Supplement: nutritional support']}, {'type': 'NO_INTERVENTION', 'label': 'Routine hospital management group', 'description': 'All participants in this group will receive routine hospital management, without additional nutritional interventions.'}], 'interventions': [{'name': 'nutritional support', 'type': 'DIETARY_SUPPLEMENT', 'description': 'nutritional support', 'armGroupLabels': ['Nutritional support therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101149', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chest Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of General Surgery', 'investigatorFullName': 'Zhu-ming Jiang', 'investigatorAffiliation': 'Peking Union Medical College'}}}}