Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06023251
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrition Adequacy', 'timeFrame': 'The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.', 'description': 'Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': "The objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry.\n\nThis enables the investigators to address, within a clinical/scientific context, a recently demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel, comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a clear objective: to address the nutritional deficit in all patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 years\n* ICU stay ≥ 7 days\n* Ward stay ≥ 3 days\n* Nutritional therapy not restricted\n* Heterogeneous diseases\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* ICU \\< 7 days\n* Ward stay \\< 3 days\n* Advanced Care Planning with impact on nutritional therapy\n* Patients with palliative care\n* Metabolic derangements such as metabolic diseases\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06023251', 'acronym': 'BrightSide', 'briefTitle': 'Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Does the Use of Supplemental Parenteral/Enteral Nutrition and/or Oral Nutrition Supplements Guided by Indirect Calorimetry Combined With Standard of Care Increases Energy Feeding Adequacy in Patients Who Survived Critical Illness?', 'orgStudyIdInfo': {'id': 'EC-2023-236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort', 'description': 'oral food, enteral nutrition, parenteral nutrition', 'interventionNames': ['Other: Clinical Nutrition']}], 'interventions': [{'name': 'Clinical Nutrition', 'type': 'OTHER', 'description': 'Nutritional care plan implementation, including\n\n* A step-up and step-down nutritional protocol guided by caloric and protein ratio\n* Monitoring plan including daily nutritional intake assessment by a dietician and (para)medical supervision by a nutrition support pharmacist and nurse concerning dysphagia, refeeding syndrome, electrolytes abnormalities and access issues\n* Indirect calorimetry measurements to assess metabolic needs and body impedance analysis to assess body composition on regular time points\n* Dedicated and specialized dietician and nurse involvement\n* Adaptive communication policy (translating to native language) and culturally appropriate food regimens and artificial nutrition.', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Elisabeth De Waele, MD, PhD', 'role': 'CONTACT', 'email': 'Elisabeth.DeWaele@uzbrussel.be', 'phone': '+32 (0)2 477 51 76'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Zenzi Rosseel, PharmD', 'role': 'CONTACT', 'email': 'zenzi.rosseel@uzbrussel.be', 'phone': '003224763344'}, {'name': 'Lotte Buyle, RD', 'role': 'CONTACT', 'email': 'lotte.buyle@uzbrussel.be', 'phone': '003224763344'}], 'overallOfficials': [{'name': 'Elisabeth De Waele, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel, Vrije universiteit Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Elisabeth De Waele', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}