Optimization of Oral Diet in Critically Ill Patients

Not Applicable

Terminated

• Conditions: Food Intake; Nutrition; Critically Ill Patients
• Interventions: Other: Personalized adapted oral diet and nutritional education

• Registration Number: NCT03354260
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-27
• Primary Completion: 2018-02-19
• Study Completion: 2018-03-27
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Personalized adapted oral diet and nutritional education	Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU

Primary Outcome Measures

Name	Time	Method
Impact on the weight 3 months after the renewal of oral intakes	at 90 days	Decrease of weight variation 3 months after the renewal of oral intakes

Secondary Outcome Measures

Name	Time	Method
mortality at D90	at 90 days	mortality on the 90th day after renewal of oral intakes
length of stay in Intensive car unit	until the 90th day	number of days in Intensive car unit in 3 months after renewal of oral intakes
weight at D30	at 30 days	weight on the 30th day after renewal of oral intakes
mortality at D30	at 30 days	mortality on the 30th day after renewal of oral intakes
length of stay in rehabilitation center	until the 90th day	number of days in rehabilitation center in 3 months after renewal of oral intakes
infectious and non infectious complications	until the 90th day	number and type of complication in 3 months after renewal of oral intakes
length of stay in Hospital	until the 90th day	number of days in Hospital in 3 months after renewal of oral intakes
quality of life and autonomy	at 90 days	SF 36 Score from 0 to 100

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Montpellier, France