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Recruiting NCT06330610

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

No phase Interventional Intermittent Fasting Septic Shock Organ Failure, Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent enteral nutrition.
Who it may be relevant to
Registry conditions: Intermittent Fasting, Septic Shock, Organ Failure, Multiple. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. [Time frame: day-1 (nutrition start) and day-7]
Secondary outcome measures (11)
  • evaluation of caloric intake [Time frame: from day-1 (nutrition start) to day-7]
  • evaluation of protein intake [Time frame: from day-1 (nutrition start) to day-7]
  • Measurement of nutritionnal status [Time frame: day-1 (nutrition start) and day-7]
  • Evaluation of the digestive tolerance [Time frame: from day-1 (nutrition start) to day-7]
  • Evaluation of the nosocomial infections [Time frame: from day-1 (nutrition start) to day-7]
  • Adverse events [Time frame: from day-1 (nutrition start) to day-7]
  • Evaluation of the metabolic response [Time frame: day 1, day 4 and day 7]
  • Evaluation of the duration of hospitalisation [Time frame: day 1 to day 90]
  • Evaluation of the intensive care neuromuscular weakness [Time frame: Up to day 10]
  • Evaluation of death [Time frame: from day 1 to day 90]
  • Evaluation of quality of life [Time frame: up to day 90]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Rouen — Rouen

Publications

  • Atherton PJ, Etheridge T, Watt PW, Wilkinson D, Selby A, Rankin D, Smith K, Rennie MJ. Muscle full effect after oral protein: time-dependent concordance and discordance between human muscle protein synthesis and mTORC1 signaling. Am J Clin Nutr. 2010 Nov;92(5):1080-8. doi: 10.3945/ajcn.2010.29819. Epub 2010 Sep 15. PMID 20844073
  • McNelly AS, Bear DE, Connolly BA, Arbane G, Allum L, Tarbhai A, Cooper JA, Hopkins PA, Wise MP, Brealey D, Rooney K, Cupitt J, Carr B, Koelfat K, Damink SO, Atherton PJ, Hart N, Montgomery HE, Puthucheary ZA. Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial. Chest. 2020 Jul;158(1):183-194. doi: 10.1016/j.chest.2020.03.045. Epub 2020 Apr 2. PMID 32247714
  • Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10. PMID 32651634
  • Marcheva B, Ramsey KM, Peek CB, Affinati A, Maury E, Bass J. Circadian clocks and metabolism. Handb Exp Pharmacol. 2013;(217):127-55. doi: 10.1007/978-3-642-25950-0_6. PMID 23604478
  • Baggs JE, Hogenesch JB. Genomics and systems approaches in the mammalian circadian clock. Curr Opin Genet Dev. 2010 Dec;20(6):581-7. doi: 10.1016/j.gde.2010.08.009. PMID 20926286
  • Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234. PMID 31151228
  • Pickel L, Sung HK. Feeding Rhythms and the Circadian Regulation of Metabolism. Front Nutr. 2020 Apr 17;7:39. doi: 10.3389/fnut.2020.00039. eCollection 2020. PMID 32363197
  • Gunst J. Recovery from critical illness-induced organ failure: the role of autophagy. Crit Care. 2017 Aug 7;21(1):209. doi: 10.1186/s13054-017-1786-y. PMID 28784175

Identifiers

NCT: NCT06330610 · 2021/0378/HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗