Nutritional SupportIONICNCT06342895
Interpretation and Optimization of Nutrition in the Intensive Care Units
A study testing Nutritional support prescription and delivery monitoring feedback in people with Nutritional Support, run by Dim3 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Support
- What is being tested?
- Nutritional support prescription and delivery monitoring feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Lille
Lille, 59037
Eric KIPNIS, MD, PhD, +33 (0)3 20 44 59 62, eric.kipnis@chu-lille.fr
About this study
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.
Read more
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
- Being tested
- Nutritional support prescription and delivery monitoring feedback, Usual care
- Keywords
- Intensive Care Unit, Protein Calorie Malnutrition, Refeeding syndrome, Clinical Decision Support Systems
- Medical subject headings
- Protein-Energy Malnutrition, Refeeding Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional support prescription and delivery monitoring feedbackDevice
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
Usual careDevice
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 group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Device: Nutritional support prescription and delivery monitoring feedback |
| control | Other | Not described Receives: Device: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: 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 (%)
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 %
Measured: 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)
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 %
Measured: 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 %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From ICU admission (Day1) to Day 28
ICU length-of-stay (days)
Days patient present in the ICU
Measured: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
Days on ventilator (days)
Days patient on ventilator
Measured: From ICU admission (Day1) to ICU discharge, data censored at Day 28 max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start10 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dim3
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation, University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Eric KIPNIS, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342895
- Sponsor's protocol ID
- 2020_1113
- Other IDs
- 2022-A00103-40
- Acronym
- IONIC
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpretation and Optimization of Nutrition in the Intensive Care Units
- ClinicalTrials.gov ID
- NCT06342895
- Acronym / sponsor ID
- IONIC / 2020_1113
- Conditions
- Nutritional Support
- Keywords
- Intensive Care Unit, Protein Calorie Malnutrition, Refeeding syndrome, Clinical Decision Support Systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Dim3Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation, University Hospital, Lille
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Nutritional support prescription and delivery monitoring feedback |
| control | Other | Device: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional support prescription and delivery monitoring feedbackReal-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 | Interventional |
| Usual careUsual 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. | Device | control |
Primary outcome
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
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 %
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric KIPNIS, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional support prescription and delivery monitoring feedback in people with Nutritional Support, run by Dim3 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric KIPNIS, MD,PhD (+33 (0)3 20 44 59 62, eric.kipnis@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.