Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:39 PM
Study NCT ID:
NCT03354260
Status:
TERMINATED
Last Update Posted:
2018-04-11
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Oral Diet in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'lack of patient intube more than 5 days', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-11-23', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on the weight 3 months after the renewal of oral intakes', 'timeFrame': 'at 90 days', 'description': 'Decrease of weight variation 3 months after the renewal of oral intakes'}], 'secondaryOutcomes': [{'measure': 'weight at D30', 'timeFrame': 'at 30 days', 'description': 'weight on the 30th day after renewal of oral intakes'}, {'measure': 'mortality at D30', 'timeFrame': 'at 30 days', 'description': 'mortality on the 30th day after renewal of oral intakes'}, {'measure': 'mortality at D90', 'timeFrame': 'at 90 days', 'description': 'mortality on the 90th day after renewal of oral intakes'}, {'measure': 'length of stay in Intensive car unit', 'timeFrame': 'until the 90th day', 'description': 'number of days in Intensive car unit in 3 months after renewal of oral intakes'}, {'measure': 'length of stay in Hospital', 'timeFrame': 'until the 90th day', 'description': 'number of days in Hospital in 3 months after renewal of oral intakes'}, {'measure': 'length of stay in rehabilitation center', 'timeFrame': 'until the 90th day', 'description': 'number of days in rehabilitation center in 3 months after renewal of oral intakes'}, {'measure': 'infectious and non infectious complications', 'timeFrame': 'until the 90th day', 'description': 'number and type of complication in 3 months after renewal of oral intakes'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 15 days', 'description': 'score of autonomy Katz Score from 0 to 6'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 15 days', 'description': 'SF 36 Score from 0 to 100'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 30 days', 'description': 'score of autonomy Katz Score from 0 to 6'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 30 days', 'description': 'SF 36 Score from 0 to 100'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 60 days', 'description': 'score of autonomy Katz Score from 0 to 6'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 60 days', 'description': 'SF 36 Score from 0 to 100'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 90 days', 'description': 'score of autonomy Katz Score from 0 to 6'}, {'measure': 'quality of life and autonomy', 'timeFrame': 'at 90 days', 'description': 'SF 36 Score from 0 to 100'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Intake', 'Critically Ill Patients', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.', 'detailedDescription': 'This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group\n\nControl group:\n\n* Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients\n* Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.\n* Nutritional evaluation before the release of resuscitation.\n\nIntervention group:\n\n* NAP: "Customized Adapted Nutrition"\n* Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.\n* Therapeutic education.\n* Nutritional evaluation before the release of resuscitation.\n* Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food\n\nThe prospects for optimizing oral replenishment are multiple:\n\n* reduce morbidity and mortality within 3 months after a stay in intensive care unit.\n* improve autonomy and quality of life after a stay in intensive care.\n* improve the privileged relationship with the patients\' families.\n* strengthen links within the resuscitation team and with downstream services.\n* Educate patients on a nutritional level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress\n\nExclusion Criteria:\n\n* age under 18 yo, pregnancy,\n* protected patients\n* moribund patient (life expectancy of 48h or below),\n* patient with disorders of swallowing\n* tracheostomy\n* patient with shock and/or respiratory distress'}, 'identificationModule': {'nctId': 'NCT03354260', 'acronym': 'NAP-REA', 'briefTitle': 'Optimization of Oral Diet in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life', 'orgStudyIdInfo': {'id': '9661'}, 'secondaryIdInfos': [{'id': '15715B-31', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU', 'interventionNames': ['Other: Personalized adapted oral diet and nutritional education']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Personalized adapted oral diet and nutritional education', 'type': 'OTHER', 'description': 'Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Celine Dupy-Richard, dietitian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}