Clinical trial NCT06342895: Interpretation and Optimization of Nutrition in the Intensive Care Units
Official title: Interpretation and Optimization of Nutrition in the Intensive Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional Support
Keywords: Intensive Care Unit
Protein Calorie Malnutrition
Refeeding syndrome
Clinical Decision Support Systems
Lead sponsor: Dim3
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
name: University Hospital, Lille
First posted: 2024-04-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over.
* French Social Security system registration.
* First stay in ICU
* Admitted to the Lille University Hospital Surgical ICU for at least 3 days.
* Active enteral and/or parenteral nutritional support prescription
* Patient and/or next-of-kin informed about the study and having consented to participation in the study.

Exclusion Criteria:

* Age under 18
* Burn patient
* Admitted to the ICU with a prior active enteral/parenteral nutritional support before day 3, except trophic nutrition
* Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
* Adult under guardianship
* Department of corrections inmate

Primary outcomes:
measure: Mean total daily calories delivered/prescribed ratio (percent)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
Secondary outcomes:
measure: Mean total daily protein delivered/prescribed ratio (%)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Mean total daily calories delivered/recommended ratio (percent)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Mean total daily protein delivered/recommended ratio (percent)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Nutritional support duration (days)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Time to initiation of nutritional support (days)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Weight (Kg)
timeFrame: From ICU Day 3 to Day 28 or until any of the following if before day 28: Return to oral intake Discharge from the ICU Death
measure: Day 28 mortality rate
timeFrame: From ICU admission (Day1) to Day 28
measure: ICU length-of-stay (days)
timeFrame: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
measure: Days on ventilator (days)
timeFrame: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital Lille
Study officials:
affiliation: University Hospital, Lille
name: Eric KIPNIS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: