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

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ClinicalTrials.gov Identifier: NCT03354260
Recruitment Status : Terminated (lack of patient intube more than 5 days)
First Posted : November 27, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Food Intake Critically Ill Patients Nutrition Other: Personalized adapted oral diet and nutritional education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : February 19, 2018
Actual Study Completion Date : March 27, 2018

Arm Intervention/treatment
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

No Intervention: Control



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. weight at D30 [ Time Frame: at 30 days ]
    weight on the 30th day after renewal of oral intakes

  2. mortality at D30 [ Time Frame: at 30 days ]
    mortality on the 30th day after renewal of oral intakes

  3. mortality at D90 [ Time Frame: at 90 days ]
    mortality on the 90th day after renewal of oral intakes

  4. length of stay in Intensive car unit [ Time Frame: until the 90th day ]
    number of days in Intensive car unit in 3 months after renewal of oral intakes

  5. length of stay in Hospital [ Time Frame: until the 90th day ]
    number of days in Hospital in 3 months after renewal of oral intakes

  6. length of stay in rehabilitation center [ Time Frame: until the 90th day ]
    number of days in rehabilitation center in 3 months after renewal of oral intakes

  7. infectious and non infectious complications [ Time Frame: until the 90th day ]
    number and type of complication in 3 months after renewal of oral intakes

  8. quality of life and autonomy [ Time Frame: at 15 days ]
    score of autonomy Katz Score from 0 to 6

  9. quality of life and autonomy [ Time Frame: at 15 days ]
    SF 36 Score from 0 to 100

  10. quality of life and autonomy [ Time Frame: at 30 days ]
    score of autonomy Katz Score from 0 to 6

  11. quality of life and autonomy [ Time Frame: at 30 days ]
    SF 36 Score from 0 to 100

  12. quality of life and autonomy [ Time Frame: at 60 days ]
    score of autonomy Katz Score from 0 to 6

  13. quality of life and autonomy [ Time Frame: at 60 days ]
    SF 36 Score from 0 to 100

  14. quality of life and autonomy [ Time Frame: at 90 days ]
    score of autonomy Katz Score from 0 to 6

  15. quality of life and autonomy [ Time Frame: at 90 days ]
    SF 36 Score from 0 to 100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354260


Locations
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France
University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Celine Dupy-Richard, dietitian Montpellier University Hospital
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03354260    
Other Study ID Numbers: 9661
15715B-31 ( Other Identifier: ANSM )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes