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Набор скоро начнётся NCT07440368

Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness

— Наблюдательное Patients Admitted to the ICU Expected Hospital Stay ≥48 Hours Adult

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: Plasma and urine I-FABP measurement.
Кому может быть актуально
Состояния в реестре: Patients Admitted to the ICU, Expected Hospital Stay ≥48 Hours, Adult. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Enterocyte Injury and Acute Gastrointestinal Dysfunction in Critical Illness: A Prospective Observational Study of Blood and Urinary Intestinal Fatty Acid-Binding Protein(Implications for Sepsis Heterogeneity）

Обзор

Acute gastrointestinal injury (AGI) is a common but not fully understood organ dysfunction in critically ill patients. Current AGI grading systems rely primarily on clinical presentation and feeding tolerance, which are inherently subjective and may not accurately reflect the underlying biological severity of intestinal damage. Intestinal fatty acid-binding protein (I-FABP) is a protein expressed almost exclusively in the cytoplasm of mature small intestinal epithelial cells. In cases of ischemia, inflammation, or mechanical injury, I-FABP is rapidly released into the bloodstream and subsequently excreted in the urine. These characteristics make I-FABP a highly specific biomarker for intestinal epithelial cell injury and intestinal ischemia. A prospective study combining paired blood and urine I-FABP measurements, standardized AGI assessment, and careful consideration of surgical status was conducted to elucidate the role of intestinal epithelial cell injury in acute gastrointestinal dysfunction.

Подробное описание

This study is a prospective observational cohort study conducted in an adult intensive care unit. Biological samples and clinical data will be prospectively collected according to a pre-defined protocol, without any intervention other than standard treatment.

Primary objective: To prospectively assess the association between serum and urinary I-FABP levels and the severity of acute gastrointestinal injury in critically ill patients.

Secondary objectives: To investigate the relationship between serum and urinary I-FABP levels and clinical outcomes (including severe AGI and mortality); to explore whether the intestinal epithelial cell injury patterns reflected by serum and urinary I-FABP are associated with different sepsis subphenotypes; and to evaluate the impact of gastrointestinal surgery on I-FABP levels and its modifying effect on the association between I-FABP and AGI severity.

Вмешательства

  • Другое Plasma and urine I-FABP measurement
    Paired plasma and urine samples will be collected within 24 hours of ICU admission to quantify intestinal fatty acid-binding protein (I-FABP) concentrations (continuous measures) using a standardized laboratory assay. A second paired sampling will be performed on ICU day 3 to assess changes over time. No therapeutic intervention is assigned; this study is observational.

Первичные конечные точки

  • Maximum AGI grade during ICU stay (ESICM 0-IV) [Срок оценки: From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.]
Вторичные конечные точки (4)
  • Severe AGI during ICU stay (AGI grade III-IV) [Срок оценки: From ICU admission (Day 1) through ICU discharge or death, assessed daily, up to 28 days.]
  • 28-day all-cause mortality [Срок оценки: Up to 28 days after ICU admission.]
  • ICU length of stay [Срок оценки: From ICU admission(Day 1) through ICU discharge or death, up to 28 days.]
  • Sepsis subphenotype characterized by an intestinal epithelial cell injury pattern [Срок оценки: Within 24 hours of ICU admission and ICU day 3 (for classification), with outcomes assessed during ICU stay and/or up to day 28 as applicable.]

Критерии участия

Критерии включения

  • 1、 Age ≥18 years.
  • 2 、Admission to the ICU with an expected ICU stay ≥48 hours.
  • 3 、Availability of paired plasma and urine samples within 24 hours of ICU admission.
  • 4 、Feasible daily gastrointestinal function assessment to complete AGI grading (ESICM definition).

Критерии исключения

  • 1、 Pre-existing inflammatory bowel disease.
  • 2 、Short bowel syndrome.
  • 3、 Chronic intestinal failure requiring long-term parenteral nutrition.
  • 4、 Pregnancy.
  • 5 、Refusal or withdrawal of informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07440368 · I-FABP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗