Interpretation and Optimization of Nutrition in the Intensive Care Units

Not Applicable

Recruiting

• Conditions: Nutritional Support
• Interventions: Device: Nutritional support prescription and delivery monitoring feedback; Device: Usual care

• Registration Number: NCT06342895
• Lead Sponsor: Dim3

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Study Start: 2024-04-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	Nutritional support prescription and delivery monitoring feedback	-
control	Usual care	-

Primary Outcome Measures

Name	Time	Method
Mean total daily calories delivered/prescribed ratio (percent)	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	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 %

Secondary Outcome Measures

Name	Time	Method
ICU length-of-stay (days)	From ICU admission (Day1) to ICU discharge, data censored at Day 28 max	Days patient present in the ICU
Mean total daily protein delivered/prescribed ratio (%)	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	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 %
Nutritional support duration (days)	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	Days on nutritional support (either parenteral and/or enteral) over the study period
Days on ventilator (days)	From ICU admission (Day1) to ICU discharge, data censored at Day 28 max	Days patient on ventilator
Time to initiation of nutritional support (days)	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	Days elapsed from ICU admission (Day 1) to first administration of any nutritional support (either parenteral and/or enteral) over the study period
Weight (Kg)	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	Daily body weight (Kg) as weighed using weighing scale integrated in the ICU-bed
Day 28 mortality rate	From ICU admission (Day1) to Day 28	Patient death during the timeframe
Mean total daily calories delivered/recommended ratio (percent)	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	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 %
Mean total daily protein delivered/recommended ratio (percent)	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	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 %

Trial Locations

Locations (1)

University Hospital Lille; 🇫🇷 Lille, France