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Идёт набор NCT07411612

The Association Between Postoperative Inflammatory and Neurological Serum Biomarker Concentrations and Occurrence of Postoperative Delirium

— Наблюдательное Delirium - Postoperative Neuronal Damage Blood Brain Barrier Defect Postoperative Complications

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: laboratory biomarker analysis, 3D-CAM/CAM-ICU.
Кому может быть актуально
Состояния в реестре: Delirium - Postoperative, Neuronal Damage, Blood Brain Barrier Defect, Postoperative Complications. Базовые параметры: от 65 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
Австрия
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

The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study

Обзор

Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days. In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.

Вмешательства

  • Диагностический тест laboratory biomarker analysis
    Neuronal, inflammatory and stress biomarkers will be obtained preoperatively, within 2 hours after surgery, on the first, second and third postoperative day
  • Диагностический тест 3D-CAM/CAM-ICU
    3D-CAM/CAM-ICU will be performed on the evening after surgery and in the morning and evening of the first three postoperative days

Первичные конечные точки

  • Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium [Срок оценки: within three days after surgery]
Вторичные конечные точки (7)
  • Association between postoperative NSE concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Association between postoperative IL-6 concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Association between postoperative Copeptin concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Predictive value of S100B concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Predictive value of NSE concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Predictive value of IL-6 concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]
  • Predictive value of Copeptin concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days [Срок оценки: within three days after surgery]

Критерии участия

Критерии включения

  • Provide written informed consent
  • ≥ 65 years of age
  • Scheduled for elective major non-cardiac, non-intrcranial, non-vascular surgery with estimated time of surgery ≥ 2 hours

Критерии исключения

  • Patients undergoing emergency surgery
  • History of diagnosed dementia
  • Language, vision, or hearing impairments that may compromise cognitive assessments
  • Preoperative delirium
  • ICU patients undergoing surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT07411612 · SPOT_ON_BRAIN_01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗