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Clinical Trials/NCT03354260
NCT03354260
Terminated
Not Applicable

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

University Hospital, Montpellier1 site in 1 country10 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Food Intake
Sponsor
University Hospital, Montpellier
Enrollment
10
Locations
1
Primary Endpoint
Impact on the weight 3 months after the renewal of oral intakes
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
March 27, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Impact on the weight 3 months after the renewal of oral intakes

Time Frame: at 90 days

Decrease of weight variation 3 months after the renewal of oral intakes

Secondary Outcomes

  • weight at D30(at 30 days)
  • mortality at D30(at 30 days)
  • mortality at D90(at 90 days)
  • length of stay in Intensive car unit(until the 90th day)
  • length of stay in rehabilitation center(until the 90th day)
  • infectious and non infectious complications(until the 90th day)
  • length of stay in Hospital(until the 90th day)
  • quality of life and autonomy(at 90 days)

Study Sites (1)

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