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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. [Срок оценки: day-1 (nutrition start) and day-7]

Вторичные конечные точки (11)

• evaluation of caloric intake [Срок оценки: from day-1 (nutrition start) to day-7]
• evaluation of protein intake [Срок оценки: from day-1 (nutrition start) to day-7]
• Measurement of nutritionnal status [Срок оценки: day-1 (nutrition start) and day-7]
• Evaluation of the digestive tolerance [Срок оценки: from day-1 (nutrition start) to day-7]
• Evaluation of the nosocomial infections [Срок оценки: from day-1 (nutrition start) to day-7]
• Adverse events [Срок оценки: from day-1 (nutrition start) to day-7]
• Evaluation of the metabolic response [Срок оценки: day 1, day 4 and day 7]
• Evaluation of the duration of hospitalisation [Срок оценки: day 1 to day 90]
• Evaluation of the intensive care neuromuscular weakness [Срок оценки: Up to day 10]
• Evaluation of death [Срок оценки: from day 1 to day 90]
• Evaluation of quality of life [Срок оценки: up to day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU de Rouen — Rouen

Публикации

• 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

Идентификаторы

NCT: NCT06330610 · 2021/0378/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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