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NCT Number: NCT06330610

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Enteral Nutrition

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. evaluation of caloric intake

    Time frame: from day-1 (nutrition start) to day-7

    evaluation of caloric intake (kcal/day)

  2. evaluation of protein intake

    Time frame: from day-1 (nutrition start) to day-7

    evaluation of protein intake (g/kg/day)

  3. Measurement of nutritionnal status

    Time frame: day-1 (nutrition start) and day-7

    measurement of weight (kg)

  4. Evaluation of the digestive tolerance

    Time frame: from day-1 (nutrition start) to day-7

    Number of vomit (number)

  5. Evaluation of the nosocomial infections

    Time frame: from day-1 (nutrition start) to day-7

    Type of infection

  6. Adverse events

    Time frame: from day-1 (nutrition start) to day-7

    Number of adverse event

  7. Evaluation of the metabolic response

    Time frame: day 1, day 4 and day 7

    metabolomics analysis (96 proteins assay)

  8. Evaluation of the duration of hospitalisation

    Time frame: day 1 to day 90

    number of days at hospital

  9. Evaluation of the intensive care neuromuscular weakness

    Time frame: Up to day 10

    MRC score

  10. Evaluation of death

    Time frame: from day 1 to day 90

    Death data collection

  11. Evaluation of quality of life

    Time frame: up to day 90

    SF-36 score

Study contacts

Contact information is provided by the study sponsor or research team.

Fabienne TAMION, MD

CONTACT

[email protected]

+33232888261

Florian VALLIN

CONTACT

[email protected]

+33232888265 ext. 66697

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ENNUT-CI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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