Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
468 participants
OBSERVATIONAL
2017-02-13
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants 1-320
First 320 participants enrolled
High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Magnetic Resonance Imaging
MRI scan of brain
Participants 321-470
Final 150 participants enrolled
High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Magnetic Resonance Imaging
MRI scan of brain
Blood specimen collection
Blood will be collected from participants
Pupillometry
A pupillometer is a device that measures the size of the pupils.
Interventions
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High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Magnetic Resonance Imaging
MRI scan of brain
Blood specimen collection
Blood will be collected from participants
Pupillometry
A pupillometer is a device that measures the size of the pupils.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
60 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Robert Pearce, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Tanabe S, Parker M, Lennertz R, Pearce RA, Banks MI, Sanders RD. Reduced Electroencephalogram Complexity in Postoperative Delirium. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):502-506. doi: 10.1093/gerona/glab352.
White MF, Tanabe S, Casey C, Parker M, Bo A, Kunkel D, Nair V, Pearce RA, Lennertz R, Prabhakaran V, Lindroth H, Sanders RD. Relationships between preoperative cortical thickness, postoperative electroencephalogram slowing, and postoperative delirium. Br J Anaesth. 2021 Aug;127(2):236-244. doi: 10.1016/j.bja.2021.02.028. Epub 2021 Apr 15.
Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20.
Tanabe S, Mohanty R, Lindroth H, Casey C, Ballweg T, Farahbakhsh Z, Krause B, Prabhakaran V, Banks MI, Sanders RD. Cohort study into the neural correlates of postoperative delirium: the role of connectivity and slow-wave activity. Br J Anaesth. 2020 Jul;125(1):55-66. doi: 10.1016/j.bja.2020.02.027. Epub 2020 Jun 1.
Other Identifiers
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A530900
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\ANESTHESIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 1/15/25
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0374
Identifier Type: -
Identifier Source: org_study_id
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