Optimization of Oral Diet in Critically Ill Patients | NCT03354260

Studies
Optimization of Oral Diet in Critically Ill Patients

NCT03354260

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Apr 11, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Food Intake
Critically Ill Patients
Nutrition

Interventions

Personalized adapted oral diet and nutritional education

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
15715B-31	Other Identifier	ANSM

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of patient intube more than 5 days

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Feb 19, 2018Actual

Completion Date

Mar 27, 2018Actual

First Submitted Date

Oct 20, 2017

First Submission Date that Met QC Criteria

Nov 23, 2017

First Posted Date

Nov 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2018

Last Update Posted Date

Apr 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Personalized adapted oral diet and nutritional education	Other	Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
weight at D30	weight on the 30th day after renewal of oral intakes	at 30 days
mortality at D30	mortality on the 30th day after renewal of oral intakes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Celine Dupy-Richard, dietitian	Montpellier University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided