Interpretation and Optimization of Nutrition in the Intensive Care Units (IONIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Nutritional Support
• Intervention / Treatment: Device: Nutritional support prescription and delivery monitoring feedback; Device: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric KIPNIS, MD,PhD; Phone Number: +33 (0)3 20 44 59 62; Email: eric.kipnis@chu-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • University Hospital Lille
    • Contact: Eric KIPNIS, MD, PhD; Phone Number: +33 (0)3 20 44 59 62; Email: eric.kipnis@chu-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional	Device: Nutritional support prescription and delivery monitoring feedback; Real-time availability in an integrated computer interface (Nutrow) of all clinical and biological information related to nutritional support including recommended, prescribed, and delivered calories and proteins and enteral feed delivery transmitted by the Feedim medical device
Other: control	Device: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean total daily calories delivered/prescribed ratio (percent)	Total (enteral+parenteral) prescribed and delivered calories are measured daily (kcal/day). The ratio of mean total daily delivered calories over the study period divided by the mean total daily prescribed calories over the study period will be calculated and expressed as a %	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean total daily protein delivered/prescribed ratio (%)	Total (enteral+parenteral) prescribed and delivered protein are measured daily (g/day). The ratio of total mean daily delivered protein over the study period divided by the mean total daily prescribed protein over the study period will be calculated and expressed as a %	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
Nutritional support duration (days)	Days on nutritional support (either parenteral and/or enteral) over the study period	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
Time to initiation of nutritional support (days)	Days elapsed from ICU admission (Day 1) to first administration of any nutritional support (either parenteral and/or enteral) over the study period	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
Weight (Kg)	Daily body weight (Kg) as weighed using weighing scale integrated in the ICU-bed	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
Day 28 mortality rate	Patient death during the timeframe	From ICU admission (Day1) to Day 28
ICU length-of-stay (days)	Days patient present in the ICU	From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
Days on ventilator (days)	Days patient on ventilator	From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
Mean total daily calories delivered/recommended ratio (percent)	Total (enteral+parenteral) prescribed and delivered calories are measured daily (kcal/day). The ratio of mean total daily delivered calories over the study period divided by the mean total daily recommended calories (according to guidelines) over the study period will be calculated and expressed as a %	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
Mean total daily protein delivered/recommended ratio (percent)	Total (enteral+parenteral) prescribed and delivered protein are measured daily (g/day). The ratio of mean total daily delivered protein over the study period divided by the mean total daily recommended protein (according to guidelines) over the study period will be calculated and expressed as a %	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

Collaborators and Investigators

• Sponsor: Dim3
• Collaborators: Baxter Healthcare Corporation; University Hospital, Lille
• Investigators: Principal Investigator: Eric KIPNIS, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Clinical Decision Support Systems; Refeeding syndrome; Protein Calorie Malnutrition
• Other Study ID Numbers: 2020_1113; 2022-A00103-40 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No