NCT03354260

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

April 11, 2018

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 20, 2017

Last Update Submit

April 9, 2018

Conditions

Food IntakeCritically Ill PatientsNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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 Hospital

    until the 90th day

  • +10 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Personalized adapted oral diet and nutritional educationOTHER

Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Montpellier, 34295, France

Location

Study Officials

  • Celine Dupy-Richard, dietitian

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 27, 2017

Study Start

April 1, 2017

Primary Completion

February 19, 2018

Study Completion

March 27, 2018

Last Updated

April 11, 2018

Record last verified: 2017-10

Locations

FR(1)