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Идёт набор NCT03124303

Interventions for Postoperative Delirium: Biomarker-3

— Наблюдательное Delirium

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: High Density-Electroencephalogram, Magnetic Resonance Imaging, Blood specimen collection, Pupillometry.
Кому может быть актуально
Состояния в реестре: Delirium. Базовые параметры: от 60 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.

Вмешательства

  • Процедура High Density-Electroencephalogram
    EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
  • Процедура Magnetic Resonance Imaging
    MRI scan of brain
  • Процедура Blood specimen collection
    Blood will be collected from participants
  • Диагностический тест Pupillometry
    A pupillometer is a device that measures the size of the pupils.

Первичные конечные точки

  • Functional Connectivity [Срок оценки: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4]
  • Brain state change [Срок оценки: Post-operative day 1 through 4]
Вторичные конечные точки (12)
  • Inflammation [Срок оценки: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4]
  • Biomarkers [Срок оценки: Post-operative day 1 through 4]
  • Brain measurements [Срок оценки: Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4]
  • Long term cognition [Срок оценки: Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Long term post-operative cognition measured 1 year after surgery.]
  • Long term cognition [Срок оценки: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery]
  • Baseline cognition, specific and global. [Срок оценки: Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4]
  • Biomarkers and brain measurements [Срок оценки: Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.]
  • Representativeness of surgical population [Срок оценки: Pre-op MRI: up to 4 weeks prior to surgery.]
  • Genetics and delirium [Срок оценки: Pre-op blood collected up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative blood collected on postoperative days 1-4. Long term blood collected 90 days and 1 year after surgery.]
  • Postoperative amyloid beta deposition and delirium [Срок оценки: Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.]
  • Long term changes in amyloid beta deposition and delirium [Срок оценки: Pre-operative PET imaging will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative PET imaging will occur 1 year after surgery.]
  • Long term cognition [Срок оценки: Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.]

Критерии участия

Критерии включения

  • Cohort 1: Age ≥65 years
  • Cohort 2: Age ≥60 years
  • Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
  • Written Informed Consent for potential participation prior to surgery

Критерии исключения

  • Contraindication to EEG
  • Unable or unwilling to attend the follow-up appointments
  • Documented history of dementia
  • Deemed incapable of providing consent by surgical team
  • Residing in a nursing home
  • Undergoing intracranial surgery
  • Unable to complete neurocognitive testing due to language, vision or hearing impairment
  • Unable to communicate with the research staff due to language barriers
  • For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Wisconsin-Madison — Madison

Публикации

  • Lv J, Taylor J, Curtis S, Kramer K, Kunkel D, Thakur S, Nair V, Banks MI, Pearce RA, Prabhakaran V, Lennertz R, Sanders RD. One-Year Brain Structural Changes Are Associated with Postoperative Delirium and Delayed Resolution of Interleukin-6. medRxiv [Preprint]. 2026 Jun 17:2026.05.03.26352074. doi: 10.64898/2026.05.03.26352074. PMID 42145626
  • Taylor NL, Wehrman J, Banks MI, Nair V, Pearce RA, Kunkel D, Shine JM, Prabhakaran V, Lennertz R, Sanders RD. Dysfunctional resting state network connectivity predicts postoperative delirium after major surgery. Br J Anaesth. 2026 May;136(5):1509-1517. doi: 10.1016/j.bja.2025.11.036. Epub 2025 Dec 31. PMID 41475933
  • Rivera C, Kunkel D, Her M, Qureshi S, Pearce RA, Sanders RD, Lennertz R. The 3-Minute Diagnostic Confusion Assessment Method severity score correlates with the Delirium Rating Scale-Revised-98 and with biomarkers of delirium. BJA Open. 2025 Apr 21;14:100398. doi: 10.1016/j.bjao.2025.100398. eCollection 2025 Jun. PMID 40331035
  • Kunkel D, Parker M, Casey C, Krause B, Taylor J, Pearce RA, Lennertz R, Sanders RD. Impact of perioperative inflammation on days alive and at home after surgery. BJA Open. 2022 Apr 14;2:100006. doi: 10.1016/j.bjao.2022.100006. eCollection 2022 Jun. PMID 37588271
  • Taylor J, Wu JG, Kunkel D, Parker M, Rivera C, Casey C, Naismith S, Teixeira-Pinto A, Maze M, Pearce RA, Lennertz R, Sanders RD. Resolution of elevated interleukin-6 after surgery is associated with return of normal cognitive function. Br J Anaesth. 2023 Oct;131(4):694-704. doi: 10.1016/j.bja.2023.05.023. Epub 2023 Jun 27. PMID 37385855
  • Payne T, Taylor J, Casey C, Kunkel D, Parker M, Blennow K, Zetterberg H, Pearce RA, Lennertz RC, Sanders RD. Prospective analysis of plasma amyloid beta and postoperative delirium in the Interventions for Postoperative Delirium: Biomarker-3 study. Br J Anaesth. 2023 May;130(5):546-556. doi: 10.1016/j.bja.2023.01.020. Epub 2023 Feb 25. PMID 36842841
  • Taylor J, Payne T, Casey C, Kunkel D, Parker M, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, McCulloch T, Gaskell A, Sanders RD. Sevoflurane dose and postoperative delirium: a prospective cohort analysis. Br J Anaesth. 2023 Feb;130(2):e289-e297. doi: 10.1016/j.bja.2022.08.022. Epub 2022 Oct 1. PMID 36192219
  • Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8. PMID 35144802

Идентификаторы

NCT: NCT03124303 · 2015-0374 · 1K23AG055700-01A1 · 1R01AG063849-01 · A530900 · SMPH\ANESTHESIOLOGY · Protocol Version 1/15/25

Первоисточники (государственные реестры)

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