Clinical trial NCT03354260: Optimization of Oral Diet in Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Food Intake
Critically Ill Patients
Nutrition
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Impact on the weight 3 months after the renewal of oral intakes
timeFrame: at 90 days
Secondary outcomes:
measure: weight at D30
timeFrame: at 30 days
measure: mortality at D30
timeFrame: at 30 days
measure: mortality at D90
timeFrame: at 90 days
measure: length of stay in Intensive car unit
timeFrame: until the 90th day
measure: length of stay in Hospital
timeFrame: until the 90th day
measure: length of stay in rehabilitation center
timeFrame: until the 90th day
measure: infectious and non infectious complications
timeFrame: until the 90th day
measure: quality of life and autonomy
timeFrame: at 15 days
measure: quality of life and autonomy
timeFrame: at 15 days
measure: quality of life and autonomy
timeFrame: at 30 days
measure: quality of life and autonomy
timeFrame: at 30 days
measure: quality of life and autonomy
timeFrame: at 60 days
measure: quality of life and autonomy
timeFrame: at 60 days
measure: quality of life and autonomy
timeFrame: at 90 days
measure: quality of life and autonomy
timeFrame: at 90 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Celine Dupy-Richard, dietitian
role: PRINCIPAL_INVESTIGATOR
References: