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Идёт набор NCT06845865

Measurement of Intestinal Permeability in Intensive Care Patients With Single or Multiple Organ Failure

— Наблюдательное Multivisceral Failure Syndrome Monovisceral Failure Infection in ICU

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: enteric dyed solution.
Кому может быть актуально
Состояния в реестре: Multivisceral Failure Syndrome, Monovisceral Failure, Infection in ICU. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Обзор

Multivisceral failure syndrome (MVFS) in humans is associated with a very high risk of mortality, ranging between 30 and 50%. This syndrome is associated with significant systemic inflammation and a high risk of bacteremia, the origin of which is not always identified. Among the possible causes of bacteremia, digestive translocation is the most probable but has not been formally proven to date. This translocation is made possible by the numerous cellular and metabolic alterations secondary to MVFS, which can lead to increased intestinal barrier permeability. Intestinal permeability is currently not systematically evaluated in clinical practice in humans. This increased intestinal permeability, associated with the presence of inflammatory markers and a septic state, has been studied in several animal models ranging from the fruit fly (Drosophila) to the mouse. These studies have shown a high risk of mortality associated with increased intestinal permeability. We propose to use this methodology in intensive care patients with at least one organ failure to investigate the link between increased intestinal permeability and survival chances.

Вмешательства

  • Пищевая добавка enteric dyed solution
    Oral administration of 0.5 mg/kg of body weight of food coloring dye

Первичные конечные точки

  • intestinal failure and survival 90 days post inclusion [Срок оценки: 2024-2027]
Вторичные конечные точки (1)
  • intestinal permeability as a function of organ failure [Срок оценки: 2024-2027]

Критерии участия

Критерии включения

Patient with single organ failure, secondary to sepsis, hospitalized in intensive care for a foreseeable duration of > 48 hours

  • SAPS2 between 20 and 40 at the sixth hour after the diagnosis of organ failure.
  • Consent from the patient or their trusted person.
  • Affiliation to a social security system.
  • Functional digestive tract and possible feeding (per os or via a nasogastric tube whose indication was determined independently of the study's needs).

Second group of patients with multi-organ failure:

  • Multi-organ failure syndrome with at least 2 organ failures, secondary to sepsis.
  • SAPS2 between 60 and 80 at the sixth hour after the diagnosis of organ failure.
  • Consent from the patient or their trusted person.
  • Affiliation to a social security system.
  • Functional digestive tract and possible feeding (conscious patient able to swallow or with a nasogastric tube whose indication was determined independently of the study's needs).

Критерии исключения

  • Pregnant and breastfeeding women;
  • Minors;
  • Persons under administrative and judicial supervision;
  • Absence of a functional digestive tract (patient unable to swallow and absence of a nasogastric tube, contraindication to enteral feeding);
  • Patients with gastroparesis;
  • Refusal of the patient or their trusted person;
  • Patient with a SAPS2 at the sixth hour after the diagnosis of organ failure < 20 or between 40 and 60 or > 80.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hopital Bégin — Vincennes

Публикации

  • Angarita SAK, Duarte S, Russell TA, Ruchala P, Elliott IA, Whitelegge JP, Zarrinpar A. Quantitative Measure of Intestinal Permeability Using Blue Food Coloring. J Surg Res. 2019 Jan;233:20-25. doi: 10.1016/j.jss.2018.07.005. Epub 2018 Jul 27. PMID 30502249
  • Dambroise E, Monnier L, Ruisheng L, Aguilaniu H, Joly JS, Tricoire H, Rera M. Two phases of aging separated by the Smurf transition as a public path to death. Sci Rep. 2016 Mar 22;6:23523. doi: 10.1038/srep23523. PMID 27002861
  • Doig CJ, Sutherland LR, Sandham JD, Fick GH, Verhoef M, Meddings JB. Increased intestinal permeability is associated with the development of multiple organ dysfunction syndrome in critically ill ICU patients. Am J Respir Crit Care Med. 1998 Aug;158(2):444-51. doi: 10.1164/ajrccm.158.2.9710092. PMID 9700119
  • Gayat E, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Azoulay E, Leone M, Oueslati H, Guidet B, Friedman D, Tesniere A, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Chevreul K, Michel M, Cholley B, Legrand M, Launay JM, Vicaut E, Singer M, Resche-Rigon M, Mebazaa A. Determinants of long-term outcome in ICU surviv PMID 29347987
  • Harris CE, Griffiths RD, Freestone N, Billington D, Atherton ST, Macmillan RR. Intestinal permeability in the critically ill. Intensive Care Med. 1992;18(1):38-41. doi: 10.1007/BF01706424. PMID 1578045

Идентификаторы

NCT: NCT06845865 · 2021PPRC02 · 2023-A02005-40

Первоисточники (государственные реестры)

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