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

NCT06330610 | Recruiting

• 1 other identifier: 2021/0378/HP
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Septic Shock; Organ Failure, Multiple

Keywords

Enteral nutrition; Mechanical ventilation; Intermittent fasting; Sepsis shock; Organ failure

Outcome Measures

Primary Outcomes (1)

• Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.

  Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition.

  day-1 (nutrition start) and day-7

Secondary Outcomes (11)

• evaluation of caloric intake

  from day-1 (nutrition start) to day-7

• evaluation of protein intake

  from day-1 (nutrition start) to day-7

• Measurement of nutritionnal status

  day-1 (nutrition start) and day-7

• Evaluation of the digestive tolerance

  from day-1 (nutrition start) to day-7

• Evaluation of the nosocomial infections

  from day-1 (nutrition start) to day-7

Study Arms (2)

Intermittent enteral nutrition

EXPERIMENTAL

patients that receive intermittent enteral nutrition.

Other: Intermittent enteral nutrition

continuous enteral nutrition

NO INTERVENTION

patients that receive continuous enteral nutrition

Interventions

Intermittent enteral nutrition OTHER

Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours.

Intermittent enteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• University Hospital, Lille: collaborator
• University Hospital, Caen: collaborator
• Amiens University Hospital: collaborator
• Centre Hospitalier Saint-Philibert, GHICL: collaborator
• Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil: collaborator
• Groupe Hospitalier du Havre: collaborator
• Centre Hospitalier de Dieppe: collaborator

Study Sites (1)

CHU de Rouen

Rouen, France, 76031, France

RECRUITING

Related Publications (23)

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  PMID: 40750277 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Fabienne TAMION, MD

CONTACT

+33232888261; fabienne.tamion@chu-rouen.fr

Florian VALLIN

CONTACT

+33232888265; florian.vallin@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 26, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): October 9, 2027
• Study Completion (Estimated): October 9, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

FR (1)