Critically Ill Patients, Food Intake, Nutrition
Conditions
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.
Interventions
OTHERPersonalized adapted oral diet and nutritional education
Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on the weight 3 months after the renewal of oral intakes | at 90 days | Decrease of weight variation 3 months after the renewal of oral intakes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality at D30 | at 30 days | mortality on the 30th day after renewal of oral intakes |
| mortality at D90 | at 90 days | mortality on the 90th day after renewal of oral intakes |
| length of stay in Intensive car unit | until the 90th day | number of days in Intensive car unit in 3 months after renewal of oral intakes |
| weight at D30 | at 30 days | weight on the 30th day after renewal of oral intakes |
| length of stay in rehabilitation center | until the 90th day | number of days in rehabilitation center in 3 months after renewal of oral intakes |
| infectious and non infectious complications | until the 90th day | number and type of complication in 3 months after renewal of oral intakes |
| quality of life and autonomy | at 15 days | score of autonomy Katz Score from 0 to 6 |
| length of stay in Hospital | until the 90th day | number of days in Hospital in 3 months after renewal of oral intakes |
Countries
France
Outcome results
None listed