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NCT03273335: INTUIT

Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults

Completed Last updated 16 November 2022
What this trial tests

trial testing Millipore biomarker assay plate in Delirium in 201 participants. Completed in 21 October 2022.

Timeline
15 June 2017
Primary endpoint
11 November 2021
21 October 2022

Quick facts

Lead sponsorDuke University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment201
Start date15 June 2017
Primary completion11 November 2021
Estimated completion21 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

Adults 60 to 130, any sex, with Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

(From NIH reporter) Each year \>16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Role of Blood-Brain Barrier Dysfunction in Delirium following Non-cardiac Surgery in Older Adults.
    Devinney MJ, Wong MK, Wright MC, Marcantonio ER, et al · · 2023 · cited 51× · PMID 37615660 · DOI 10.1002/ana.26771
  2. Flow Cytometry Characterization of Cerebrospinal Fluid Monocytes in Patients With Postoperative Cognitive Dysfunction: A Pilot Study.
    Berger M, Murdoch DM, Staats JS, Chan C, et al · · 2019 · cited 30× · PMID 31085945 · DOI 10.1213/ane.0000000000004179
  3. Electroencephalogram-Based Complexity Measures as Predictors of Post-operative Neurocognitive Dysfunction.
    Acker L, Ha C, Zhou J, Manor B, et al · · 2021 · cited 23× · PMID 34858144 · DOI 10.3389/fnsys.2021.718769
  4. A protocol to reduce self-reported pain scores and adverse events following lumbar punctures in older adults.
    Nobuhara CK, Bullock WM, Bunning T, Colin B, et al · · 2020 · cited 22× · PMID 32198714 · DOI 10.1007/s00415-020-09797-1
  5. Preoperative electroencephalographic alpha-power changes with eyes opening are associated with postoperative attention impairment and inattention-related delirium severity.
    Acker L, Wong MK, Wright MC, Reese M, et al · · 2024 · cited 12× · PMID 38087743 · DOI 10.1016/j.bja.2023.10.037
  6. EEG pre-burst suppression: characterization and inverse association with preoperative cognitive function in older adults.
    Reese M, Christensen S, Anolick H, Roberts KC, et al · · 2023 · cited 11× · PMID 37711992 · DOI 10.3389/fnagi.2023.1229081
  7. Conserved YKL-40 changes in mice and humans after postoperative delirium.
    David-Bercholz J, Acker L, Caceres AI, Wu PY, et al · · 2022 · cited 10× · PMID 36457825 · DOI 10.1016/j.bbih.2022.100555
  8. The Role of Sleep Apnea in Postoperative Neurocognitive Disorders Among Older Noncardiac Surgery Patients: A Prospective Cohort Study.
    Devinney MJ, Spector AR, Wright MC, Thomas J, et al · · 2025 · cited 4× · PMID 39688967 · DOI 10.1213/ane.0000000000007269

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