Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-04-18 @ 6:57 AM
Study NCT ID:
NCT03354260
Status:
TERMINATED
Last Update Posted:
2018-04-11
First Post:
2017-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Oral Diet in Critically Ill Patients
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of patient intube more than 5 days
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAP-REA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15715B-31 | OTHER | ANSM | View |