Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-01 @ 7:05 AM
Study NCT ID:
NCT06590350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized NUTRItional RISK and Oriented Nutritional Support
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the duration of hospitalization', 'timeFrame': '12 months', 'description': 'Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.'}], 'secondaryOutcomes': [{'measure': 'Differences in the number of infectious complications', 'timeFrame': '12 months', 'description': 'Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.'}, {'measure': 'Frequency of adherence to diet and AFMS proposed at visit', 'timeFrame': '12 months', 'description': 'requency of adherence to the prescribed diet and AFMS (Artificial Feeding and Medical Support) proposed during the visit.'}, {'measure': 'Differences in hospitalization costs for the healthcare', 'timeFrame': '12 months', 'description': 'Differences in hospitalization costs for the healthcare facility among patients at risk of malnutrition who received nutritional counseling within 72 hours of admission compared to the group of patients at risk who did not receive counseling within 72 hours of ward entry.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.', 'detailedDescription': "Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.\n\nData only of patients with NRS-2002 \\> 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).\n\nPatients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.\n\nTwo cohorts will be formed and compared:\n\nCohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.\n\nCohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.\n\nCurrently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at risk of malnutrition by default (NRS-2002 ≥3) admitted to the Admission Room Departmental Simple Operating Unit of the A. Gemelli Polyclinic Foundation in Rome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* NRS-2002 ≥3\n* Length of stay \\> 4 days\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* NRS-2002 \\<3\n* Length of stay \\< or = 4 days\n* Absence of informed consent'}, 'identificationModule': {'nctId': 'NCT06590350', 'acronym': 'NUTRISKO', 'briefTitle': 'Individualized NUTRItional RISK and Oriented Nutritional Support', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Individualized NUTRItional RISK and Oriented Nutritional Support', 'orgStudyIdInfo': {'id': '6407 - NUTRISKO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort who received clinical nutrition counseling <72 hours', 'description': 'Patients at risk of malnutrition who received clinical nutrition counseling within 72 hours.', 'interventionNames': ['Other: Clinical nutrition counseling']}, {'label': 'Cohort who did NOT received clinical nutrition counseling <72 hours', 'description': 'Patients at risk of malnutrition who did NOT receive clinical nutrition counseling within 72 hours.', 'interventionNames': ['Other: Clinical nutrition counseling']}], 'interventions': [{'name': 'Clinical nutrition counseling', 'type': 'OTHER', 'description': "In the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission.\n\nOnly patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®).\n\nThe patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case.\n\nPatient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet.\n\nCosts related to hospitalization and management of any complications will also be assessed.", 'armGroupLabels': ['Cohort who did NOT received clinical nutrition counseling <72 hours', 'Cohort who received clinical nutrition counseling <72 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Emanuele Rinninella', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Emanuele Rinninella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}