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Идёт набор NCT04523909

Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery

— Наблюдательное Postoperative Delirium Postoperative Cognitive Dysfunction Thoracic Aortic Aneurysm

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: Trajectory of neuroinflammatory proteins in CSF and blood.
Кому может быть актуально
Состояния в реестре: Postoperative Delirium, Postoperative Cognitive Dysfunction, Thoracic Aortic Aneurysm. 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
Нидерланды
Следующий шаг
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Официальное название

Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery: the TURBO Study

Обзор

Observational prospective pilot study to analyze the trajectory of neuroinflammatory protein expression in cerebrospinal fluid (CSF) in relation to systemic compartment in patients undergoing thoracic aortic surgery. The aim of this study is to identify and unravel the biochemical (neuroinflammatory) pathways involved in postoperative delirium. Patient undergoing thoracic aortic surgery will have an external lumbar drain (ELD) in situ on the day before surgery. This ELD remains in place during and three days after surgery to reduce the risk on periprocedural spinal cord ischemia. Paired measurements of CSF and blood will be analyzed.

Подробное описание

Major (cardiovascular) surgery is frequently associated with cerebral dysfunction postoperatively. Major surgical procedures account for substantial systemic inflammatory activation. Interestingly, animal models have shown that surgery rather than anaesthetics trigger a neurocognitive decline. An increase of pro-inflammatory cytokines and activation of immune cells mediate this post operative cognitive decline. There is growing support that systemic inflammation can activate the innate immune system of the brain leading to inflammation in the brain ('neuroinflammation'). This neuroinflammation is suggested to play a pivotal role in postoperative delirium and postoperative cognitive decline due to surgery-related systemic inflammation. However little evidence is available on the extend of the neuroinflammation and which biochemical pathways are dysregulated in the brain after surgery.

Thoracic aortic surgery offers the unique opportunity to study the trajectory of protein expression in CSF prior to and after surgery in a non-invasive matter. It is standard of care that an external lumbar drain (ELD) is placed the day prior to surgery and this ELD will remain in place during three postoperative days.

To advance the understanding of the impact of major surgery to the brain, the investigators wish to study the trajectory of protein expression prior to and after thoracic aortic surgery.

Вмешательства

  • Диагностический тест Trajectory of neuroinflammatory proteins in CSF and blood
    Kinetics of neuroinflammatory markers in CSF and blood

Первичные конечные точки

  • Trajectory of the concentration of a panel of inflammatory proteins in CSF [Срок оценки: 9 timepoints: Baseline (immediately before surgery); Start extracorporeal circulation; Stop extracorporeal circulation (ECC); 2 hours (h) after stop ECC; 4h after stop ECC; 6h after stop ECC; 24h after baseline; 48h after baseline; 72h after baseline]
Вторичные конечные точки (7)
  • Trajectory of the concentration of a panel of inflammatory proteins in plasma [Срок оценки: 9 timepoints: Baseline to 72 hours after surgery]
  • Trajectory of blood-CSF barrier disruption based on CSF/Plasma albumine ratio [Срок оценки: 9 timepoints: Baseline to 72 hours after surgery]
  • Occurence of postoperative delirium [Срок оценки: 14-day incidence of delirium]
  • Trajectory of brain injury markers in CSF [Срок оценки: 9 timepoints: Baseline to 72 hours after surgery]
  • Trajectory of brain injury markers in plasma [Срок оценки: 9 timepoints: Baseline to 72 hours after surgery]
  • Changes in ex vivo cytokine production after whole blood stimulation [Срок оценки: 5 timepoints: Baseline to 48 hours after surgery]
  • Changes in mHLA-DR expression [Срок оценки: 5 timepoints: Baseline to 48 hours after surgery]

Критерии участия

Критерии включения

  • Competent patients ≥ 18 years
  • Patients who will undergo thoracic aortic surgery and will therefore receive an external lumbar drain as a standard of care procedure.

Критерии исключения

  • Patients with meningitis/encephalitis/brain abscess within the last 6 months
  • Patients with other neurological conditions: brain injury (acute stroke, brain trauma or cerebral haemorrhage) within the last 3 months, known brain tumours, neurodegenerative disease or known pre-existing cognitive impairment (to a degree that would be compatible with mild cognitive impairment or more).
  • Brain or spinal surgery within the last 3 months
  • Active infection <2 weeks before surgery
  • Patients who object against storage of their body material for scientific reasons

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Department of Intensive Care Medicine, Radboud university medical center — Nijmegen

Идентификаторы

NCT: NCT04523909 · CMO 2017-3774

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗