Optimization of Oral Diet in Critically Ill Patients (NAP-REA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Critically Ill Patients; Nutrition; Food Intake
• Intervention / Treatment: Other: Personalized adapted oral diet and nutritional education

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: intervention; 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; Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Celine Dupy-Richard, dietitian, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): February 19, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 9661 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); 15715B-31 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No