Nutrition Clinical Trial
— NAP-REAOfficial 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
Verified date | October 2017 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | March 27, 2018 |
Est. primary completion date | February 19, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | weight at D30 | weight on the 30th day after renewal of oral intakes | at 30 days | |
Secondary | mortality at D30 | mortality on the 30th day after renewal of oral intakes | at 30 days | |
Secondary | mortality at D90 | mortality on the 90th day after renewal of oral intakes | at 90 days | |
Secondary | 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 | |
Secondary | length of stay in Hospital | number of days in Hospital in 3 months after renewal of oral intakes | until the 90th day | |
Secondary | length of stay in rehabilitation center | number of days in rehabilitation center in 3 months after renewal of oral intakes | until the 90th day | |
Secondary | infectious and non infectious complications | number and type of complication in 3 months after renewal of oral intakes | until the 90th day | |
Secondary | quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 15 days | |
Secondary | quality of life and autonomy | SF 36 Score from 0 to 100 | at 15 days | |
Secondary | quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 30 days | |
Secondary | quality of life and autonomy | SF 36 Score from 0 to 100 | at 30 days | |
Secondary | quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 60 days | |
Secondary | quality of life and autonomy | SF 36 Score from 0 to 100 | at 60 days | |
Secondary | quality of life and autonomy | score of autonomy Katz Score from 0 to 6 | at 90 days | |
Secondary | quality of life and autonomy | SF 36 Score from 0 to 100 | at 90 days |
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