Optimization of Oral Diet in Critically Ill Patients

Nutrition Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03354260
• Other study ID #: 9661
• Secondary ID: 15715B-31
• Status: Terminated
• Phase: N/A
• First received: October 20, 2017
• Last updated: April 9, 2018
• Start date: April 1, 2017
• Est. completion date: March 27, 2018

Study information

• Verified date: October 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Food Intake
• Nutrition

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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