Food IntakeNAP-REANCT03354260
Optimization of Oral Diet in Critically Ill Patients
A study testing Personalized adapted oral diet and nutritional education in people with Food Intake and Critically Ill Patients, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Intake, Critically Ill Patients, Nutrition
- What is being tested?
- Personalized adapted oral diet and nutritional education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 27 Mar 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
- patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress
Who cannot join
- age under 18 yo, pregnancy,
- protected patients
- moribund patient (life expectancy of 48h or below),
- patient with disorders of swallowing
- tracheostomy
- patient with shock and/or respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life
The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.
Read the detailed description
This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group
Control group:
- Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Nutritional evaluation before the release of resuscitation.
Intervention group:
- NAP: "Customized Adapted Nutrition"
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Therapeutic education.
- Nutritional evaluation before the release of resuscitation.
- Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food
The prospects for optimizing oral replenishment are multiple:
- reduce morbidity and mortality within 3 months after a stay in intensive care unit.
- improve autonomy and quality of life after a stay in intensive care.
- improve the privileged relationship with the patients' families.
- strengthen links within the resuscitation team and with downstream services.
- Educate patients on a nutritional level.
- Conditions
- Food Intake, Critically Ill Patients, Nutrition
- Being tested
- Personalized adapted oral diet and nutritional education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized adapted oral diet and nutritional educationOther
Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU Receives: Other: Personalized adapted oral diet and nutritional education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on the weight 3 months after the renewal of oral intakes
Decrease of weight variation 3 months after the renewal of oral intakes
Measured: at 90 days
Secondary outcomes (15)
weight at D30
weight on the 30th day after renewal of oral intakes
Measured: at 30 days
mortality at D30
mortality on the 30th day after renewal of oral intakes
Measured: at 30 days
mortality at D90
mortality on the 90th day after renewal of oral intakes
Measured: at 90 days
length of stay in Intensive car unit
number of days in Intensive car unit in 3 months after renewal of oral intakes
Measured: until the 90th day
length of stay in Hospital
number of days in Hospital in 3 months after renewal of oral intakes
Measured: until the 90th day
length of stay in rehabilitation center
number of days in rehabilitation center in 3 months after renewal of oral intakes
Measured: until the 90th day
infectious and non infectious complications
number and type of complication in 3 months after renewal of oral intakes
Measured: until the 90th day
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
Measured: at 15 days
quality of life and autonomy
SF 36 Score from 0 to 100
Measured: at 15 days
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
Measured: at 30 days
quality of life and autonomy
SF 36 Score from 0 to 100
Measured: at 30 days
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
Measured: at 60 days
quality of life and autonomy
SF 36 Score from 0 to 100
Measured: at 60 days
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
Measured: at 90 days
quality of life and autonomy
SF 36 Score from 0 to 100
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Apr 2017
- Primary completion19 Feb 2018
- Study completion27 Mar 2018
Why it stopped: lack of patient intube more than 5 days
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food IntakeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celine Dupy-Richard, dietitian, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354260
- Sponsor's protocol ID
- 9661
- Other IDs
- 15715B-31
- Acronym
- NAP-REA
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 11 Apr 2018
- 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 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life
- ClinicalTrials.gov ID
- NCT03354260
- Acronym / sponsor ID
- NAP-REA / 9661
- Conditions
- Food Intake, Critically Ill Patients, Nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient intube more than 5 days
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 27 Nov 2017 (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.
The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.
Detailed description
This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group
Control group:
- Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Nutritional evaluation before the release of resuscitation.
Intervention group:
- NAP: "Customized Adapted Nutrition"
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Therapeutic education.
- Nutritional evaluation before the release of resuscitation.
- Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food
The prospects for optimizing oral replenishment are multiple:
- reduce morbidity and mortality within 3 months after a stay in intensive care unit.
- improve autonomy and quality of life after a stay in intensive care.
- improve the privileged relationship with the patients' families.
- strengthen links within the resuscitation team and with downstream services.
- Educate patients on a nutritional level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Personalized adapted oral diet and nutritional educationOptimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress
Key exclusion criteria (6 listed)
- age under 18 yo, pregnancy,
- protected patients
- moribund patient (life expectancy of 48h or below),
- patient with disorders of swallowing
- tracheostomy
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 |
|---|---|---|
| Personalized adapted oral diet and nutritional educationOptimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU | Other | intervention |
Primary outcome
Impact on the weight 3 months after the renewal of oral intakes
Time frame: at 90 days
Decrease of weight variation 3 months after the renewal of oral intakes
15 secondary outcomes
weight at D30
Time frame: at 30 days
mortality at D30
Time frame: at 30 days
mortality at D90
Time frame: at 90 days
length of stay in Intensive car unit
Time frame: until the 90th day
length of stay in Hospital
Time frame: until the 90th day
length of stay in rehabilitation center
Time frame: until the 90th day
infectious and non infectious complications
Time frame: until the 90th day
quality of life and autonomy
Time frame: at 15 days
quality of life and autonomy
Time frame: at 15 days
quality of life and autonomy
Time frame: at 30 days
quality of life and autonomy
Time frame: at 30 days
quality of life and autonomy
Time frame: at 60 days
quality of life and autonomy
Time frame: at 60 days
quality of life and autonomy
Time frame: at 90 days
quality of life and autonomy
Time frame: at 90 days
Results and safety
The study was stopped early (reason given: lack of patient intube more than 5 days). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- 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.
Celine Dupy-Richard, dietitian principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized adapted oral diet and nutritional education in people with Food Intake and Critically Ill Patients, run by University Hospital, Montpellier 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 1 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: stopped early, as of the sponsor's last update on 11 Apr 2018. 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?
The study was stopped early (reason given: lack of patient intube more than 5 days). Results are not available in the source record.
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?
Impact on the weight 3 months after the renewal of oral intakes (time frame: at 90 days). 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 11 Apr 2018.