Clinical trial NCT06330610: Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit
Official title: Evaluation de l'efficacité du Support Nutritionnel entéral Intermittent Sur la défaillance d'Organes de Patients de réanimation Sous Ventilation assistée ENteral NUTrition - Continue Intermittent
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intermittent Fasting
Septic Shock
Organ Failure, Multiple
Keywords: Enteral nutrition
Mechanical ventilation
Intermittent fasting
Sepsis shock
Organ failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.

Detailed description: Some pre-clinical and observational studies have suggested that intermittent fasting may have a positive impact on patients in ICU by increasing protein synthesis, sensibility to insulin, cetogenesis, autophagy by respecting the circadian rhythm. This study aims to evaluate the impact on organ failures of an intermittent enteral nutrition versus continuous enteral nutrition in patients at the acute phase of sepsis shock with mechanical ventilation in the ICU.

Eligibility criteria: Inclusion Criteria:

* Patient admitted in ICU for less than 48h, with invasive mechanical ventilation predicted for at least 48h, that can undergo nasogastric feeding.
* Patient under vasopressive drugs
* Patient that signed collected
* Patient under healthcare system
* Age ≥ 18 years
* Affiliation to a social security scheme
* Patient who has read and understood the information letter and signed the consent form

Exclusion Criteria:

* Oesophageal varices or occlusive syndrom
* Impossibility to start enteral feeding within 48h after admission in the ICU
* Enteral nutrition started for more than one hour
* Parenteral nutrition
* Pregnant or parturient or breastfeeding woman or proven absence of contraception

Primary outcomes:
measure: Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.
timeFrame: day-1 (nutrition start) and day-7
Secondary outcomes:
measure: evaluation of caloric intake
timeFrame: from day-1 (nutrition start) to day-7
measure: evaluation of protein intake
timeFrame: from day-1 (nutrition start) to day-7
measure: Measurement of nutritionnal status
timeFrame: day-1 (nutrition start) and day-7
measure: Evaluation of the digestive symptoms
timeFrame: from day-1 (nutrition start) to day-7
measure: Evaluation of the nosocomial infections
timeFrame: from day-1 (nutrition start) to day-7
measure: Evaluation of the metabolic response
timeFrame: day 1, day 4 and day 7
measure: Evaluation of the duration of hospitalisation
timeFrame: day 1 to day 90
measure: Evaluation of the intensive care neuromuscular weakness
timeFrame: Up to day 10
measure: Evaluation of death
timeFrame: from day 1 to day 90
measure: Evaluation of quality of life
timeFrame: up to day 90
Other outcomes:
Locations:
Study officials:
References:
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