Optimization of Oral Diet in Critically Ill Patients

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03354260
Study type	Interventional
Source	University Hospital, Montpellier
Contact
Status	Terminated
Phase	N/A
Start date	April 1, 2017
Completion date	March 27, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimization of Oral Diet in Critically Ill Patients — NAP-REA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms