Optimization of Oral Diet in Critically Ill Patients (NAP-REA)
Primary Purpose
Food Intake, Critically Ill Patients, Nutrition
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized adapted oral diet and nutritional education
Sponsored by
About this trial
This is an interventional treatment trial for Food Intake
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
Control
Arm Description
Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
Outcomes
Primary Outcome Measures
Impact on the weight 3 months after the renewal of oral intakes
Decrease of weight variation 3 months after the renewal of oral intakes
Secondary Outcome Measures
weight at D30
weight on the 30th day after renewal of oral intakes
mortality at D30
mortality on the 30th day after renewal of oral intakes
mortality at D90
mortality on the 90th day after renewal of oral intakes
length of stay in Intensive car unit
number of days in Intensive car unit in 3 months after renewal of oral intakes
length of stay in Hospital
number of days in Hospital in 3 months after renewal of oral intakes
length of stay in rehabilitation center
number of days in rehabilitation center in 3 months after renewal of oral intakes
infectious and non infectious complications
number and type of complication in 3 months after renewal of oral intakes
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
quality of life and autonomy
SF 36 Score from 0 to 100
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
quality of life and autonomy
SF 36 Score from 0 to 100
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
quality of life and autonomy
SF 36 Score from 0 to 100
quality of life and autonomy
score of autonomy Katz Score from 0 to 6
quality of life and autonomy
SF 36 Score from 0 to 100
Full Information
NCT ID
NCT03354260
First Posted
October 20, 2017
Last Updated
April 9, 2018
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03354260
Brief Title
Optimization of Oral Diet in Critically Ill Patients
Acronym
NAP-REA
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of patient intube more than 5 days
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
February 19, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Intake, Critically Ill Patients, Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Personalized adapted oral diet and nutritional education
Intervention Description
Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
Primary Outcome Measure Information:
Title
Impact on the weight 3 months after the renewal of oral intakes
Description
Decrease of weight variation 3 months after the renewal of oral intakes
Time Frame
at 90 days
Secondary Outcome Measure Information:
Title
weight at D30
Description
weight on the 30th day after renewal of oral intakes
Time Frame
at 30 days
Title
mortality at D30
Description
mortality on the 30th day after renewal of oral intakes
Time Frame
at 30 days
Title
mortality at D90
Description
mortality on the 90th day after renewal of oral intakes
Time Frame
at 90 days
Title
length of stay in Intensive car unit
Description
number of days in Intensive car unit in 3 months after renewal of oral intakes
Time Frame
until the 90th day
Title
length of stay in Hospital
Description
number of days in Hospital in 3 months after renewal of oral intakes
Time Frame
until the 90th day
Title
length of stay in rehabilitation center
Description
number of days in rehabilitation center in 3 months after renewal of oral intakes
Time Frame
until the 90th day
Title
infectious and non infectious complications
Description
number and type of complication in 3 months after renewal of oral intakes
Time Frame
until the 90th day
Title
quality of life and autonomy
Description
score of autonomy Katz Score from 0 to 6
Time Frame
at 15 days
Title
quality of life and autonomy
Description
SF 36 Score from 0 to 100
Time Frame
at 15 days
Title
quality of life and autonomy
Description
score of autonomy Katz Score from 0 to 6
Time Frame
at 30 days
Title
quality of life and autonomy
Description
SF 36 Score from 0 to 100
Time Frame
at 30 days
Title
quality of life and autonomy
Description
score of autonomy Katz Score from 0 to 6
Time Frame
at 60 days
Title
quality of life and autonomy
Description
SF 36 Score from 0 to 100
Time Frame
at 60 days
Title
quality of life and autonomy
Description
score of autonomy Katz Score from 0 to 6
Time Frame
at 90 days
Title
quality of life and autonomy
Description
SF 36 Score from 0 to 100
Time Frame
at 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celine Dupy-Richard, dietitian
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optimization of Oral Diet in Critically Ill Patients
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