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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
Health authority
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

Study Design


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
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