Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
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.
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:
NCT03354260
Study Brief:
Protocol Section:
NCT03354260