protocolSection identificationModule nctId: NCT06342895, orgStudyIdInfo id: 2020_1113, secondaryIdInfos id: 2022-A00103-40, type: OTHER, domain: ID-RCB number, ANSM, briefTitle: Interpretation and Optimization of Nutrition in the Intensive Care Units, acronym: IONIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Dim3, class: INDUSTRY, collaborators name: Baxter Healthcare Corporation, collaborators name: University Hospital, Lille, descriptionModule briefSummary: Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein., conditionsModule conditions: Nutritional Support, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Usual use of standard clinical and biological information related to nutritional support as available through the ICU electronic health record (i.e. without any calculated information on recommended, prescribed, or received calories and protein, only information on prescribed products and volumes as collected by and presented in the ICU EHR) In this arm, participants, investigators, and healthcare professionals will be blinded to real-time enteral feed volumes that will be collected by the Feedim medical device and transmitted to the electronic study case report form., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional support prescription and delivery monitoring feedback, interventions name: Usual care, outcomesModule primaryOutcomes measure: Mean total daily calories delivered/prescribed ratio (percent), secondaryOutcomes measure: Mean total daily protein delivered/prescribed ratio (%), secondaryOutcomes measure: Mean total daily calories delivered/recommended ratio (percent), secondaryOutcomes measure: Mean total daily protein delivered/recommended ratio (percent), secondaryOutcomes measure: Nutritional support duration (days), secondaryOutcomes measure: Time to initiation of nutritional support (days), secondaryOutcomes measure: Weight (Kg), secondaryOutcomes measure: Day 28 mortality rate, secondaryOutcomes measure: ICU length-of-stay (days), secondaryOutcomes measure: Days on ventilator (days), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Lille, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: Eric KIPNIS, MD, PhD, role: CONTACT, phone: +33 (0)3 20 44 59 62, email: eric.kipnis@chu-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, hasResults: False