Optimization of Oral Diet in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Food Intake, Critically Ill Patients, Nutrition

Intervention / Treatment
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* Other: Personalized adapted oral diet and nutritional education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU | Other: Personalized adapted oral diet and nutritional education<br>* Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on the weight 3 months after the renewal of oral intakes | Decrease of weight variation 3 months after the renewal of oral intakes | at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight at D30 | weight on the 30th day after renewal of oral intakes | at 30 days | 
| mortality at D30 | mortality on the 30th day after renewal of oral intakes | at 30 days | 
| mortality at D90 | mortality on the 90th day after renewal of oral intakes | 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 | until the 90th day | 
| length of stay in Hospital | number of days in Hospital in 3 months after renewal of oral intakes | until the 90th day | 
| length of stay in rehabilitation center | number of days in rehabilitation center in 3 months after renewal of oral intakes | until the 90th day | 
| infectious and non infectious complications | number and type of complication in 3 months after renewal of oral intakes | until the 90th day | 
| quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 15 days | 
| quality of life and autonomy | SF 36 Score from 0 to 100 | at 15 days | 
| quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 30 days | 
| quality of life and autonomy | SF 36 Score from 0 to 100 | at 30 days | 
| quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 60 days | 
| quality of life and autonomy | SF 36 Score from 0 to 100 | at 60 days | 
| quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 90 days | 
| quality of life and autonomy | SF 36 Score from 0 to 100 | at 90 days |