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Набор скоро начнётся NCT06849011

Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

Наблюдательное Stroke Acute Encephalitis Non-traumatic Brain Injury

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Stroke Acute, Encephalitis, Non-traumatic Brain Injury. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers

Обзор

The study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. This model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.

Подробное описание

A multi-center, prospective case data collection study will be conducted across 19 tertiary hospitals in China. Based on this, a predictive assessment model for poor prognosis in neurocritically ill patients receiving enteral nutrition support will be developed and validated, using key inflammatory and metabolic markers. During the data collection process, comprehensive clinical information will be extracted, including patient demographic data, clinical indicators, and hematological markers. By conducting in-depth analysis and processing of this vast and detailed clinical and laboratory data, a nomogram for predicting poor prognosis in neurocritical care patients receiving enteral nutrition support will be constructed using statistical methods and data analysis techniques in R. Once the model is built, it will undergo rigorous validation on an independent external dataset to ensure its accuracy and reliability. The goal is to create a precise assessment tool for clinicians, helping them to quickly and accurately identify high-nutritional-risk patients, thereby providing a solid scientific foundation for the formulation of individualized nutrition support strategies, ultimately improving the prognosis of neurocritical patients.

Первичные конечные точки

  • All-cause mortality at Day 28 of enteral nutrition therapy [Срок оценки: From enrollment to 28 days after the initiation of enteral nutrition]
Вторичные конечные точки (12)
  • Nutritional goal achievement rate at Day 3 (caloric and protein intake reaching 70%-100% of calculated target) [Срок оценки: At Day 3 after the initiation of enteral nutrition]
  • Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3) [Срок оценки: At Day 90 after the initiation of enteral nutrition]
  • Incidence of infectious complications within 14 days (including pneumonia, urinary tract infections, bloodstream infections, skin infections, and Clostridium difficile infections) [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Gastrointestinal intolerance within 14 days (gastric residual volume > 200 mL, nausea, vomiting, bloating, diarrhea) [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Incidence of gastrointestinal bleeding within 14 days (gastric occult blood, fecal occult blood, hematemesis, melena, hematochezia) [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Number of days with random blood glucose > 10 mmol/L within 14 days [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Average daily insulin requirement within 14 days [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Incidence of hypophosphatemia within 3 days [Срок оценки: Within 3 days after the initiation of enteral nutrition]
  • Duration of mechanical ventilation within 14 days [Срок оценки: Within 14 days after the initiation of enteral nutrition]
  • Length of NICU stay [Срок оценки: From enrollment to discharge from the NICU, up to 1 year.]
  • Total hospital stay duration [Срок оценки: From enrollment to discharge, up to 1 year.]
  • 90-day readmission rate post-discharge [Срок оценки: Within 90 days after discharge]

Критерии участия

Критерии включения

  • Age between 18 and 80 years, no gender restrictions.
  • Within 7 days of disease onset and expected NICU stay of at least 7 days.
  • Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
  • Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
  • NRS 2002 score ≥3.
  • Kuwata drinking test ≥ grade 3.
  • Acute Gastrointestinal Injury (AGI) grade 1 or 2.
  • Signed informed consent obtained from the patient or their legal representative.

Критерии исключения

  • Severe malnutrition prior to admission, defined as BMI < 16 kg/m².
  • Pregnant or lactating women.
  • Receiving hypothermia treatment or core body temperature < 36°C.
  • End-stage disease with an expected survival time of < 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability.
  • Malignant tumors.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 19 центров
  • Beijing Hui People's Hospital — Пекин
  • Xuanwu Hospital, Capital Medical University — Пекин
  • You'anmen Hospital — Пекин
  • The Ninth Medical Center of Chinese PLA General Hospital — Пекин
  • The 940th Hospital of Joint Logistics Support Force of Chinese PLA — Lanzhou
  • Guizhou Provincial People's Hospital — Guiyang
  • Affiliated Hospital of Zunyi Medical University — Zunyi
  • Tangshan People's Hospital — Tangshan
  • … и ещё 11 центров

Идентификаторы

NCT: NCT06849011 · xwzc202500102

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗