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

June 25, 2025 updated by: University Hospital, Rouen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent enteral nutrition
patients that receive intermittent enteral nutrition.
Other: Intermittent enteral nutrition
Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours.
No Intervention: continuous enteral nutrition
patients that receive continuous enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.
Time Frame: day-1 (nutrition start) and day-7
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

University Hospital, Caen
University Hospital, Lille
Amiens University Hospital
Groupe Hospitalier du Havre
Centre Hospitalier de Dieppe
Centre Hospitalier Intercommunal Elbeuf-Louviers / Val de Reuil
Centre Hospitalier Saint-Philibert, GHICL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

October 9, 2027

Study Completion (Estimated)

October 9, 2027

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0378/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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