Interpretation and Optimization of Nutrition in the Intensive Care Units

Overview

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.

Interventions

• 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
• 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 Feedi

Primary outcome measures

• Mean total daily calories delivered/prescribed ratio (percent) [Time frame: 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 (9)

• Mean total daily protein delivered/prescribed ratio (%) [Time frame: 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 calories delivered/recommended ratio (percent) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: From ICU admission (Day1) to Day 28]
• ICU length-of-stay (days) [Time frame: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max]
• Days on ventilator (days) [Time frame: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• University Hospital Lille — Lille

Identifiers

NCT: NCT06342895 · 2020_1113 · 2022-A00103-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗