Intensive CareNutriSaveNCT01749488
The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care
A study testing Designated dietitian for the ward in people with Intensive Care, run by Centre Hospitalier Universitaire de Nīmes.
Trial summary
The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care. Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care
- What is being tested?
- Designated dietitian for the ward
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Apr 2018
- 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
- The patient must be insured or beneficiary of a health insurance plan
- Patients hospitalized in intensive care for an expected period greater than 72 hours, and for whom sufficient eating after 72 hours of hospitalization is deemed unlikely upon admission.
- Patients receiving mechanical ventilation and having at least one organ failure other than respiratory failure, defined by a SOFA score greater than 2.
Who cannot join
- The patient is under judicial protection
- The patient (or his/her legal representative or "trusted-person") indicates they do not wish to participate in the study
- It is impossible to correctly inform either the patient or his/her "trusted person"
- The patient is participating in another study, or is in an exclusion period determined by another study
- Moribund patients or those for whom death appears imminent (within 24 hours)
- Survival to Day 28 unlikely due to uncontrollable comorbidities
- Patients with advanced directives issued expressing the wish to not be resuscitated
About this study
Official title: The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance
The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care.
Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received.
This is a randomized-cluster study; participating centers are randomized into experimental and control groups.
Read the detailed description
The secondary objectives of this study are to compare the impact of the intervention of a dietician on:
- daily and accumulated energy balance at the end of the intensive care unit (ICU) stay
- deficits in protein intake per day, accumulated over 7 days, and accumulated for the ICU stay
- intake of vitamins, trace elements and pharmaco-nutrients per day
- predominant route of nutrition administration (enteral / parenteral / mixed)
- the course of the stay: duration of mechanical ventilation, organ failure, the ICU stay, number of days on antibiotics
- the presence / absence of complications: mortality, on catheter bacteremia, ventilator acquired pneumonia, other infections, bedsores, episodes of hyper-or hypoglycemia
- presence/absence of diarrhea
- costs related to the management of malnourished patients in terms of enteral and parenteral nutritional therapy, dietary supplements, antibiotics and sedatives as well as the costs of ICU stay and those related to diarrhea and sores
- Conditions
- Intensive Care
- Being tested
- Designated dietitian for the ward
- Keywords
- Dietitian, Nutritional recommendations, ICU nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designated dietitian for the wardOther
This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care.
| Study group | Role | What they receive |
|---|---|---|
| Control intensive care wards | No intervention | This is a randomized cluster trial. The centers randomized into this arm will serve as controls. No interventions will be implemented for these centers. |
| Experimental intensive care wards | Experimental | This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care.
Intervention: Designated dietitian for the ward Receives: Other: Designated dietitian for the ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric deficit accumulated over 7 days
Caloric deficit accumulated over 7 days (kcal/kg)
Measured: Day 7
Secondary outcomes (54)
Average per day caloric deficit
Average per day caloric deficit (kcal/kg/day)
Measured: Day 7
Caloric deficit accumulated during the ICU stay
Caloric deficit accumulated during the ICU stay (kcal/kg)
Measured: ICU discharge (maximum of 28 days)
Average per-day protein deficit
Average per-day protein deficit (grams protein/kg/day)
Measured: Day 7
Protein deficit accumulated over 7 days
Protein deficit accumulated over 7 days (grams protein/kg)
Measured: Day 7
Protein deficit accumulated during the ICU stay
Protein deficit accumulated during the ICU stay (grams protein/kg)
Measured: ICU discharge (maximum of 28 days)
Average per day amounts of vitamins received
Measured: Day 7
Average per day amounts of trace elements received
Measured: Day 7
Average per day amounts of pharmaco nutrients received
Measured: Day 7
Percentage of calories received by enteral route
daily average
Measured: Day 7
Percentage of calories received by enteral route
accumulated over 7 days
Measured: Day 7
Percentage of calories received by enteral route
accumulated over ICU stay
Measured: ICU discharge (maximum of 28 days)
Percentage of proteins received by enteral route
daily average
Measured: Day 7
Percentage of proteins received by enteral route
accumulated over 7 days
Measured: Day 7
Percentage of proteins received by enteral route
accumulated over ICU stay
Measured: ICU discharge (maximum of 28 days)
length of time spent on ventilator (hours)
Measured: ICU discharge (maximum of 28 days)
length of ICU stay (days)
Measured: ICU discharge (maximum of 28 days)
Number of days spent with (any) organ failure
Measured: ICU discharge (maximum of 28 days)
Number of days on antibiotics
Measured: ICU discharge (maximum of 28 days)
Mortality (yes/no)
Measured: Day 90
Mortality (yes/no)
Measured: Day 180
Presence/absence of on-catheter bacteremia
Measured: Day 7
Presence/absence of on-catheter bacteremia
Measured: Day 28
Presence/absence of on-catheter bacteremia
Measured: ICU discharge (maximum of 28 days)
Presence/absence of ventilator acquired pneumonia
Measured: Day 7
Presence/absence of ventilator acquired pneumonia
Measured: Day 28
Presence/absence of ventilator acquired pneumonia
Measured: ICU discharge (maximum of 28 days)
Presence/absence of other infections
Measured: Day 7
Presence/absence of other infections
Measured: Day 28
Presence/absence of other infections
Measured: ICU discharge (maximum of 28 days)
Presence/absence of bed sores
Measured: Day 7
Presence/absence of bed sores
Measured: Day 28
Presence/absence of bed sores
Measured: ICU discharge (maximum of 28 days)
Composite score for complications
Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores
Measured: Day 7
Composite score for complications
Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores
Measured: Day 28
Composite score for complications
Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores
Measured: ICU discharge (maximum of 28 days)
Minimum observed glycemia
Measured: Day 7
Minimum observed glycemia
Measured: ICU discharge (maximum of 28 days)
Maximum observed glycemia
Measured: Day 7
Maximum observed glycemia
Measured: ICU discharge (maximum of 28 days)
Average observed glycemia
Measured: Day 7
Average observed glycemia
Measured: ICU discharge (maximum of 28 days)
Presence/absence of a glycemia measure < 0.4 g/l
Measured: Day 7
Presence/absence of a glycemia measure < 0.4 g/l
Measured: ICU discharge (maximum of 28 days)
Presence/absence of a glycemia measure > 1.8 g/l
Measured: Day 7
Presence/absence of a glycemia measure > 1.8 g/l
Measured: ICU discharge (maximum of 28 days)
Presence/absence of hypertriglyceridemia
Measured: Day 7
Presence/absence of hypertriglyceridemia
Measured: ICU discharge (maximum of 28 days)
Accumulated cost of enteral nutrition
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Accumulated cost of parenteral nutrition
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Accumulated cost of antibiotics
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Accumulated cost of sedation
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Presence/absence of diarrhea
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Accumulated cost of nutritional supplements
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Accumulated cost of ICU stay
Measured: Between Day 0 and ICU discharge (expected maximum of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: The intervention becomes obsolete for participating centres pending regulatories.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saber Davide Barbar, MD, Principal investigator, Centre Hospitalier Universitaire de NīmesJean-Yves Lefrant, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749488
- Sponsor's protocol ID
- PHRC-I/2012/SB-01
- Other IDs
- 2012-A00626-37
- Acronym
- NutriSave
- Status last verified
- Aug 2016
- First submitted
- 12 Dec 2012
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance
- ClinicalTrials.gov ID
- NCT01749488
- Acronym / sponsor ID
- NutriSave / PHRC-I/2012/SB-01
- Conditions
- Intensive Care
- Keywords
- Dietitian, Nutritional recommendations, ICU nutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The intervention becomes obsolete for participating centres pending regulatories.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Dec 2012 (estimated)
- 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.
The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care.
Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received.
This is a randomized-cluster study; participating centers are randomized into experimental and control groups.
Detailed description
The secondary objectives of this study are to compare the impact of the intervention of a dietician on:
- daily and accumulated energy balance at the end of the intensive care unit (ICU) stay
- deficits in protein intake per day, accumulated over 7 days, and accumulated for the ICU stay
- intake of vitamins, trace elements and pharmaco-nutrients per day
- predominant route of nutrition administration (enteral / parenteral / mixed)
- the course of the stay: duration of mechanical ventilation, organ failure, the ICU stay, number of days on antibiotics
- the presence / absence of complications: mortality, on catheter bacteremia, ventilator acquired pneumonia, other infections, bedsores, episodes of hyper-or hypoglycemia
- presence/absence of diarrhea
- costs related to the management of malnourished patients in terms of enteral and parenteral nutritional therapy, dietary supplements, antibiotics and sedatives as well as the costs of ICU stay and those related to diarrhea and sores
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control intensive care wards | No intervention | –This is a randomized cluster trial. The centers randomized into this arm will serve as controls. No interventions will be implemented for these centers. |
| Experimental intensive care wards | Experimental | Other: Designated dietitian for the wardThis is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care. Intervention: Designated dietitian for the ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must be insured or beneficiary of a health insurance plan
- Patients hospitalized in intensive care for an expected period greater than 72 hours, and for whom sufficient eating after 72 hours of hospitalization is deemed unlikely upon admission.
- Patients receiving mechanical ventilation and having at least one organ failure other than respiratory failure, defined by a SOFA score greater than 2.
Key exclusion criteria (7 listed)
- The patient is under judicial protection
- The patient (or his/her legal representative or "trusted-person") indicates they do not wish to participate in the study
- It is impossible to correctly inform either the patient or his/her "trusted person"
- The patient is participating in another study, or is in an exclusion period determined by another study
- Moribund patients or those for whom death appears imminent (within 24 hours)
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 |
|---|---|---|
| Designated dietitian for the wardThis is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care. | Other | Experimental intensive care wards |
Primary outcome
Caloric deficit accumulated over 7 days
Time frame: Day 7
Caloric deficit accumulated over 7 days (kcal/kg)
54 secondary outcomes
Average per day caloric deficit
Time frame: Day 7
Caloric deficit accumulated during the ICU stay
Time frame: ICU discharge (maximum of 28 days)
Average per-day protein deficit
Time frame: Day 7
Protein deficit accumulated over 7 days
Time frame: Day 7
Protein deficit accumulated during the ICU stay
Time frame: ICU discharge (maximum of 28 days)
Average per day amounts of vitamins received
Time frame: Day 7
Average per day amounts of trace elements received
Time frame: Day 7
Average per day amounts of pharmaco nutrients received
Time frame: Day 7
Percentage of calories received by enteral route
Time frame: Day 7
Percentage of calories received by enteral route
Time frame: Day 7
Percentage of calories received by enteral route
Time frame: ICU discharge (maximum of 28 days)
Percentage of proteins received by enteral route
Time frame: Day 7
Percentage of proteins received by enteral route
Time frame: Day 7
Percentage of proteins received by enteral route
Time frame: ICU discharge (maximum of 28 days)
length of time spent on ventilator (hours)
Time frame: ICU discharge (maximum of 28 days)
length of ICU stay (days)
Time frame: ICU discharge (maximum of 28 days)
Number of days spent with (any) organ failure
Time frame: ICU discharge (maximum of 28 days)
Number of days on antibiotics
Time frame: ICU discharge (maximum of 28 days)
Mortality (yes/no)
Time frame: Day 90
Mortality (yes/no)
Time frame: Day 180
Presence/absence of on-catheter bacteremia
Time frame: Day 7
Presence/absence of on-catheter bacteremia
Time frame: Day 28
Presence/absence of on-catheter bacteremia
Time frame: ICU discharge (maximum of 28 days)
Presence/absence of ventilator acquired pneumonia
Time frame: Day 7
Presence/absence of ventilator acquired pneumonia
Time frame: Day 28
Presence/absence of ventilator acquired pneumonia
Time frame: ICU discharge (maximum of 28 days)
Presence/absence of other infections
Time frame: Day 7
Presence/absence of other infections
Time frame: Day 28
Presence/absence of other infections
Time frame: ICU discharge (maximum of 28 days)
Presence/absence of bed sores
Time frame: Day 7
Presence/absence of bed sores
Time frame: Day 28
Presence/absence of bed sores
Time frame: ICU discharge (maximum of 28 days)
Composite score for complications
Time frame: Day 7
Composite score for complications
Time frame: Day 28
Composite score for complications
Time frame: ICU discharge (maximum of 28 days)
Minimum observed glycemia
Time frame: Day 7
Minimum observed glycemia
Time frame: ICU discharge (maximum of 28 days)
Maximum observed glycemia
Time frame: Day 7
Maximum observed glycemia
Time frame: ICU discharge (maximum of 28 days)
Average observed glycemia
Time frame: Day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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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.
Saber Davide Barbar, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
Jean-Yves Lefrant, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
Questions about this trial
What is this clinical trial studying?
A study testing Designated dietitian for the ward in people with Intensive Care, run by Centre Hospitalier Universitaire de Nīmes.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric deficit accumulated over 7 days (time frame: Day 7). 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 18 Jun 2026.