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

NCT ID: NCT06330610

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2027-10-09

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.

Conditions

Intermittent Fasting; Septic Shock; Organ Failure, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intermittent enteral nutrition

patients that receive intermittent enteral nutrition.

Group Type: EXPERIMENTAL

Intermittent enteral nutrition

Intervention Type: OTHER

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

continuous enteral nutrition

patients that receive continuous enteral nutrition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intermittent enteral nutrition

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

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: collaborator

Amiens University Hospital

OTHER

Sponsor Role: collaborator

Centre Hospitalier Saint-Philibert, GHICL

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

OTHER_GOV

Sponsor Role: collaborator

Groupe Hospitalier du Havre

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Dieppe

UNKNOWN

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Rouen

Rouen, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabienne TAMION, MD

Role: CONTACT

fabienne.tamion@chu-rouen.fr

+33232888261

Florian VALLIN

Role: CONTACT

florian.vallin@chu-rouen.fr

+33232888265 ext. 66697

Facility Contacts

Fabienne TAMION, MD

Role: primary

fabienne.tamion@chu-rouen.fr

+33232888261

Florian VALLIN

Role: backup

florian.vallin@chu-rouen.fr

+33232888265

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Other Identifiers

2021/0378/HP

Identifier Type: -

Identifier Source: org_study_id