Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit

Not Applicable

Not yet recruiting

• Conditions: Septic Shock; Intermittent Fasting; Organ Failure, Multiple
• Interventions: Other: Intermittent enteral nutrition

• Registration Number: NCT06330610
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Study Start: 2024-05-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent enteral nutrition	Intermittent enteral nutrition	patients that receive intermittent enteral nutrition.

Primary Outcome Measures

Name	Time	Method
Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.	day-1 (nutrition start) and day-7	Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the metabolic response	day 1, day 4 and day 7	metabolomics analysis (96 proteins assay)
Evaluation of the intensive care neuromuscular weakness	Up to day 10	MRC score
evaluation of caloric intake	from day-1 (nutrition start) to day-7	evaluation of caloric intake (kcal/day)
Evaluation of the digestive symptoms	from day-1 (nutrition start) to day-7	Number of vomit (number)
Evaluation of the nosocomial infections	from day-1 (nutrition start) to day-7	Type of infection
Evaluation of death	from day 1 to day 90	Death data collection
Evaluation of quality of life	up to day 90	SF-36 score
evaluation of protein intake	from day-1 (nutrition start) to day-7	evaluation of protein intake (g/kg/day)
Measurement of nutritionnal status	day-1 (nutrition start) and day-7	measurement of weight (kg)
Evaluation of the duration of hospitalisation	day 1 to day 90	number of days at hospital