Interpretation and Optimization of Nutrition in the Intensive Care Units

NCT06342895 | Recruiting

• 2 other identifiers: 2020_11132022-A00103-40
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Support

Keywords

Intensive Care Unit; Protein Calorie Malnutrition; Refeeding syndrome; Clinical Decision Support Systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Interventional

EXPERIMENTAL

Device: Nutritional support prescription and delivery monitoring feedback

control

OTHER

Device: Usual care

Interventions

Nutritional support prescription and delivery monitoring feedback DEVICE

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

Interventional

Usual care DEVICE

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.

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dim3: lead
• Baxter Healthcare Corporation: collaborator
• University Hospital, Lille: collaborator

Study Sites (1)

University Hospital Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Protein-Energy Malnutrition; Refeeding Syndrome

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Eric KIPNIS, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric KIPNIS, MD,PhD

CONTACT

+33 (0)3 20 44 59 62; eric.kipnis@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: April 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

FR (1)