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

U

University Hospital, Rouen

Status

Enrolling

Conditions

Organ Failure, Multiple
Intermittent Fasting
Septic Shock

Treatments

Other: Intermittent enteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT06330610
2021/0378/HP

Details and patient eligibility

About

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.

Full 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.

Enrollment

174 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

174 participants in 2 patient groups

Intermittent enteral nutrition
Experimental group
Description:
patients that receive intermittent enteral nutrition.
Treatment:
Other: Intermittent enteral nutrition
continuous enteral nutrition
No Intervention group
Description:
patients that receive continuous enteral nutrition

Trial contacts and locations

1

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Central trial contact

Florian VALLIN; Fabienne TAMION, MD

Data sourced from clinicaltrials.gov

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