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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 20, 2017
First Posted Date  ICMJE November 27, 2017
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date February 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • weight at D30 [ Time Frame: at 30 days ]
    weight on the 30th day after renewal of oral intakes
  • mortality at D30 [ Time Frame: at 30 days ]
    mortality on the 30th day after renewal of oral intakes
  • mortality at D90 [ Time Frame: at 90 days ]
    mortality on the 90th day after renewal of oral intakes
  • 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
  • length of stay in Hospital [ Time Frame: until the 90th day ]
    number of days in Hospital in 3 months after renewal of oral intakes
  • 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
  • infectious and non infectious complications [ Time Frame: until the 90th day ]
    number and type of complication in 3 months after renewal of oral intakes
  • quality of life and autonomy [ Time Frame: at 15 days ]
    score of autonomy Katz Score from 0 to 6
  • quality of life and autonomy [ Time Frame: at 15 days ]
    SF 36 Score from 0 to 100
  • quality of life and autonomy [ Time Frame: at 30 days ]
    score of autonomy Katz Score from 0 to 6
  • quality of life and autonomy [ Time Frame: at 30 days ]
    SF 36 Score from 0 to 100
  • quality of life and autonomy [ Time Frame: at 60 days ]
    score of autonomy Katz Score from 0 to 6
  • quality of life and autonomy [ Time Frame: at 60 days ]
    SF 36 Score from 0 to 100
  • quality of life and autonomy [ Time Frame: at 90 days ]
    score of autonomy Katz Score from 0 to 6
  • quality of life and autonomy [ Time Frame: at 90 days ]
    SF 36 Score from 0 to 100
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
  • weight at D30 [ Time Frame: at 30 days ]
    weight on the 30th day after renewal of oral intakes
  • mortality at D30 [ Time Frame: at 30 days ]
    mortality on the 30th day after renewal of oral intakes
  • mortality at D90 [ Time Frame: at 90 days ]
    mortality on the 90th day after renewal of oral intakes
  • 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
  • length of stay in Hospital [ Time Frame: until the 90th day ]
    number of days in Hospital in 3 months after renewal of oral intakes
  • 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
  • infectious and non infectious complications [ Time Frame: until the 90th day ]
    number and type of complication in 3 months after renewal of oral intakes
  • quality of life and autonomy [ Time Frame: at 15 days ]
    Katz Score
  • quality of life and autonomy [ Time Frame: at 15 days ]
    SF 36
  • quality of life and autonomy [ Time Frame: at 30 days ]
    Katz Score
  • quality of life and autonomy [ Time Frame: at 30 days ]
    SF 36
  • quality of life and autonomy [ Time Frame: at 60 days ]
    Katz Score
  • quality of life and autonomy [ Time Frame: at 60 days ]
    SF 36
  • quality of life and autonomy [ Time Frame: at 90 days ]
    Katz Score
  • quality of life and autonomy [ Time Frame: at 90 days ]
    SF 36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimization of Oral Diet in Critically Ill Patients
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Food Intake
  • Critically Ill Patients
  • Nutrition
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: intervention
    Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
    Intervention: Other: Personalized adapted oral diet and nutritional education
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 19, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2017)
50
Actual Study Completion Date  ICMJE March 27, 2018
Actual Primary Completion Date February 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354260
Other Study ID Numbers  ICMJE 9661
15715B-31 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Celine Dupy-Richard, dietitian Montpellier University Hospital
PRS Account University Hospital, Montpellier
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP