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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
| University Hospital, Caen | OTHER |
| Amiens University Hospital | OTHER |
| Centre Hospitalier Saint-Philibert, GHICL |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent enteral nutrition | Experimental | patients that receive intermittent enteral nutrition. |
|
| continuous enteral nutrition | No Intervention | patients that receive continuous enteral nutrition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent enteral nutrition | Other | Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. | Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition. | day-1 (nutrition start) and day-7 |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of caloric intake | evaluation of caloric intake (kcal/day) | from day-1 (nutrition start) to day-7 |
| evaluation of protein intake | evaluation of protein intake (g/kg/day) |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabienne TAMION, MD | Contact | +33232888261 | fabienne.tamion@chu-rouen.fr | |
| Florian VALLIN | Contact | +33232888265 | 66697 | florian.vallin@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rouen | Recruiting | Rouen | France | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20844073 | Background | 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. | |
| 32247714 | Background |
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| UNKNOWN |
| Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil | OTHER_GOV |
| Groupe Hospitalier du Havre | OTHER |
| Centre Hospitalier de Dieppe | UNKNOWN |
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| from day-1 (nutrition start) to day-7 |
| Measurement of nutritionnal status | measurement of weight (kg) | day-1 (nutrition start) and day-7 |
| Evaluation of the digestive tolerance | Number of vomit (number) | from day-1 (nutrition start) to day-7 |
| Evaluation of the nosocomial infections | Type of infection | from day-1 (nutrition start) to day-7 |
| Adverse events | Number of adverse event | from day-1 (nutrition start) to day-7 |
| Evaluation of the metabolic response | metabolomics analysis (96 proteins assay) | day 1, day 4 and day 7 |
| Evaluation of the duration of hospitalisation | number of days at hospital | day 1 to day 90 |
| Evaluation of the intensive care neuromuscular weakness | MRC score | Up to day 10 |
| Evaluation of death | Death data collection | from day 1 to day 90 |
| Evaluation of quality of life | SF-36 score | up to day 90 |
| 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. |
| 32651634 | Background | 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. |
| 23604478 | Background | 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. |
| 20926286 | Background | 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. |
| 31151228 | Background | 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. |
| 32363197 | Background | 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. |
| 28784175 | Background | 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. |
| 21270330 | Background | Vanhorebeek I, Gunst J, Derde S, Derese I, Boussemaere M, Guiza F, Martinet W, Timmermans JP, D'Hoore A, Wouters PJ, Van den Berghe G. Insufficient activation of autophagy allows cellular damage to accumulate in critically ill patients. J Clin Endocrinol Metab. 2011 Apr;96(4):E633-45. doi: 10.1210/jc.2010-2563. Epub 2011 Jan 26. |
| 24461665 | Background | Hermans G, Casaer MP, Clerckx B, Guiza F, Vanhullebusch T, Derde S, Meersseman P, Derese I, Mesotten D, Wouters PJ, Van Cromphaut S, Debaveye Y, Gosselink R, Gunst J, Wilmer A, Van den Berghe G, Vanhorebeek I. Effect of tolerating macronutrient deficit on the development of intensive-care unit acquired weakness: a subanalysis of the EPaNIC trial. Lancet Respir Med. 2013 Oct;1(8):621-629. doi: 10.1016/S2213-2600(13)70183-8. Epub 2013 Sep 10. |
| 29107505 | Background | Martinez-Lopez N, Tarabra E, Toledo M, Garcia-Macia M, Sahu S, Coletto L, Batista-Gonzalez A, Barzilai N, Pessin JE, Schwartz GJ, Kersten S, Singh R. System-wide Benefits of Intermeal Fasting by Autophagy. Cell Metab. 2017 Dec 5;26(6):856-871.e5. doi: 10.1016/j.cmet.2017.09.020. Epub 2017 Oct 26. |
| 28826372 | Background | Newman JC, Verdin E. beta-Hydroxybutyrate: A Signaling Metabolite. Annu Rev Nutr. 2017 Aug 21;37:51-76. doi: 10.1146/annurev-nutr-071816-064916. |
| 27475046 | Background | Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27. |
| 26645687 | Background | Zou X, Meng J, Li L, Han W, Li C, Zhong R, Miao X, Cai J, Zhang Y, Zhu D. Acetoacetate Accelerates Muscle Regeneration and Ameliorates Muscular Dystrophy in Mice. J Biol Chem. 2016 Jan 29;291(5):2181-95. doi: 10.1074/jbc.M115.676510. Epub 2015 Dec 8. |
| 31262340 | Background | Goossens C, Weckx R, Derde S, Dufour T, Vander Perre S, Pauwels L, Thiessen SE, Van Veldhoven PP, Van den Berghe G, Langouche L. Adipose tissue protects against sepsis-induced muscle weakness in mice: from lipolysis to ketones. Crit Care. 2019 Jul 1;23(1):236. doi: 10.1186/s13054-019-2506-6. |
| 31471173 | Background | Stekovic S, Hofer SJ, Tripolt N, Aon MA, Royer P, Pein L, Stadler JT, Pendl T, Prietl B, Url J, Schroeder S, Tadic J, Eisenberg T, Magnes C, Stumpe M, Zuegner E, Bordag N, Riedl R, Schmidt A, Kolesnik E, Verheyen N, Springer A, Madl T, Sinner F, de Cabo R, Kroemer G, Obermayer-Pietsch B, Dengjel J, Sourij H, Pieber TR, Madeo F. Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans. Cell Metab. 2019 Sep 3;30(3):462-476.e6. doi: 10.1016/j.cmet.2019.07.016. Epub 2019 Aug 27. |
| 31881139 | Background | de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available. |
| 28219766 | Background | Thiessen SE, Van den Berghe G, Vanhorebeek I. Mitochondrial and endoplasmic reticulum dysfunction and related defense mechanisms in critical illness-induced multiple organ failure. Biochim Biophys Acta Mol Basis Dis. 2017 Oct;1863(10 Pt B):2534-2545. doi: 10.1016/j.bbadis.2017.02.015. Epub 2017 Feb 17. |
| 31107308 | Background | Van Dyck L, Casaer MP. Intermittent or continuous feeding: any difference during the first week? Curr Opin Crit Care. 2019 Aug;25(4):356-362. doi: 10.1097/MCC.0000000000000617. |
| 30294835 | Background | Deane AM, Chapman MJ, Reintam Blaser A, McClave SA, Emmanuel A. Pathophysiology and Treatment of Gastrointestinal Motility Disorders in the Acutely Ill. Nutr Clin Pract. 2019 Feb;34(1):23-36. doi: 10.1002/ncp.10199. Epub 2018 Oct 7. |
| 32448392 | Background | Van Dyck L, Vanhorebeek I, Wilmer A, Schrijvers A, Derese I, Mebis L, Wouters PJ, Van den Berghe G, Gunst J, Casaer MP. Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study. Crit Care. 2020 May 24;24(1):249. doi: 10.1186/s13054-020-02987-3. |
| 30348463 | Background | Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29. |
| 40750277 | Derived | Tebani A, Demailly Z, Bekri S, Maizel J, Marchalot A, Bourel C, Du Cheyron D, Michot JB, Schnell G, Vanderlinden T, Tamion F. Clinical and metabolic phenotyping of continuous versus intermittent ENteral NUTrition in ventilated adults with shock: ENNUT trial protocol. BMJ Open. 2025 Aug 1;15(7):e099761. doi: 10.1136/bmjopen-2025-099761. |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D012772 | Shock, Septic |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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