ClinicalTrials.Veeva

Menu

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

D

Dim3

Status

Enrolling

Conditions

Nutritional Support

Treatments

Device: Usual care
Device: Nutritional support prescription and delivery monitoring feedback

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06342895
2022-A00103-40 (Other Identifier)
2020_1113

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

144 participants in 2 patient groups

Interventional
Experimental group
Treatment:
Device: Nutritional support prescription and delivery monitoring feedback
control
Other group
Treatment:
Device: Usual care

Trial contacts and locations

1

Loading...

Central trial contact

Eric KIPNIS, MD,PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems