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

Not Applicable

Recruiting

• Conditions: Septic Shock; Intermittent Fasting; Organ Failure, Multiple

• 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

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-26
• Study Start: 2024-07-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2027-10-09
• Study Completion: 2027-10-09

Recruitment & Eligibility

• Status: 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 for 7 days.

• Patient under vasopressive drugs

• Adult patients (age ≥ 18 years)

• Informed person who has read and signed their consent

  • If the patient is unable to sign their consent (emergency situation), the consent will be signed by a trusted person or a family member, and consent to continue the study will be requested subsequently.
  • If the patient is unable to sign their consent (emergency situation) and no trusted person is present, the patient may be included in the study. In this case, consent to continue the study will be requested from a trusted person as soon as possible, or from the patient if they are able to understand and sign the consent.

• Affiliation to a social security scheme

• No current pregnancy: for women of childbearing age, a beta-HCG blood pregnancy test will be performed upon inclusion; for postmenopausal women, a confirmatory diagnosis must be obtained.

Exclusion Criteria

• Contraindication to enteral nutrition and/or nasogastric tube insertion: esophageal varices and occlusive syndrome
• Artificial enteral nutrition that cannot be initiated within 48 hours of intubation
• Enteral nutrition ongoing for more than one hour at the time of inclusion
• Need for exclusive or supplemental parenteral nutrition
• Moribund patient
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 death	from day 1 to day 90	Death data collection
evaluation of caloric intake	from day-1 (nutrition start) to day-7	evaluation of caloric intake (kcal/day)
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 digestive tolerance	from day-1 (nutrition start) to day-7	Number of vomit (number)
Evaluation of the metabolic response	day 1, day 4 and day 7	metabolomics analysis (96 proteins assay)
Evaluation of quality of life	up to day 90	SF-36 score
Evaluation of the nosocomial infections	from day-1 (nutrition start) to day-7	Type of infection
Adverse events	from day-1 (nutrition start) to day-7	Number of adverse event
Evaluation of the duration of hospitalisation	day 1 to day 90	number of days at hospital
Evaluation of the intensive care neuromuscular weakness	Up to day 10	MRC score

Trial Locations

Locations (1)

CHU de Rouen; 🇫🇷 Rouen, France