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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG055700-01A1 | U.S. NIH Grant/Contract | View source | |
| 1R01AG063849-01 | U.S. NIH Grant/Contract | View source | |
| A530900 | Other Identifier | UW Madison | |
| SMPH\ANESTHESIOLOGY | Other Identifier | UW Madison | |
| Protocol Version 1/15/25 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants 1-320 | First 320 participants enrolled |
| |
| Participants 321-470 | Final 150 participants enrolled |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Density-Electroencephalogram | Procedure | EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Connectivity | Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4 |
| Brain state change | Quantified by the MSD across regions of interest from resting state time-series to randomly spaced points across the time-series. Measured for Cohort 2 only. | Post-operative day 1 through 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Assess the changes from preoperative to postoperative EEG associated with delirium and change in plasma/cerebrospinal fluid (CSF) IL-6 or other biomarkers (e.g. other cytokines or markers of neronal injury) | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4 |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort 1: Patients, 65 years of age and older, undergoing surgery with an estimated length of stay of 2 days or greater.
Cohort 2: Patients, 60 years of age and older, undergoing surgery with an estimated length of stay of 2 days or greater.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Kunkel, BS | Contact | 608-262-6469 | dkunkel@wisc.edu | |
| Frankie Ingram, BS | Contact | 608-262-6469 | fingram@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Pearce, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42145626 | Derived | 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 May 8:2026.05.03.26352074. doi: 10.64898/2026.05.03.26352074. | |
| 41475933 | Derived | 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. |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
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Participant blood and cerebrospinal fluid (CSF) will be collected and stored for future analysis.
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| Magnetic Resonance Imaging | Procedure | MRI scan of brain |
|
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| Blood specimen collection | Procedure | Blood will be collected from participants |
|
| Pupillometry | Diagnostic Test | A pupillometer is a device that measures the size of the pupils. |
|
| Biomarkers |
Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry) |
| Post-operative day 1 through 4 |
| Brain measurements | Assess the association between preoperative white matter connectivity (DTI) and cortical thickness (derived from MRI) and postoperative delirium | Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4 |
| Long term cognition | Examine the incidence of delirium with change in cognition from preoperatively to one-year postoperatively. | 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 | Assess the impact of delirium, preoperative and postoperative imaging biomarkers with a change in long term cognition | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery |
| Baseline cognition, specific and global. | Examine the association between preoperative cognition using a neuropsychological battery, and postoperative delirium incidence. | Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4 |
| Biomarkers and brain measurements | Assess the changes in cognition and biomarkers over one year with EEG changes. | Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery. |
| Representativeness of surgical population | Identify whether patients who consent to the MRI are reflective of the surgical population. | Pre-op MRI: up to 4 weeks prior to surgery. |
| Genetics and delirium | Identify genetic and epigenetic changes associated with delirium and its pathogenesis. | 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 | Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography at 90 days after surgery in sub-study IPOD-PET. | 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 | Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography preoperatively and 1 year after surgery in sub-study IPOD-PET2. | 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 | Identify predictors of delirium severity and incidence, for change in cognition from preoperatively to two-years postoperatively. | Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery. |
| Mismatch negativity | EEG mismatch negativity during delirium compared to resolution of delirium. | Post-operative day 1 through 4 |
| Resolution of slow wave activity | Slow wave activity during delirium compared to resolution of delirium. | Post-operative day 1 through 4 |
| Connectivity during delirium | Dynamic causal modeling of cortical connectivity during delirium. | Post-operative day 1 through 4 |
| Effects of inflammation on brain activity | EEG correlations with biomarkers of inflammation and neuronal injury. | Post-operative day 1 through 4 |
| Delirium subtypes - neuronal dynamics | EEG neuronal dynamics (energy landscape analysis) during hyperactive vs hypoactive delirium. | Post-operative day 1 through 4 |
| Delirium subtypes - predisposing neuronal dynamics | Preoperative neuronal dynamics between hyperactive and hypoactive delirium. | Up to 4 weeks prior to surgery. |
| Delirium subtypes - network stitching | Task evoked network switching and locus coeruleus activity between hyperactive and hypoactive delirium. | Post-operative day 1 through 4 |
| Delirium subtypes - network integration | Preoperative brain network integration vs differentiation between hyperactive and hypoactive delirium. | Up to 4 weeks prior to surgery. |
| Pupillary responses | Pupillary response during rest and cognitive task in delirious versus nondelirious participants. | Post-operative day 1 through 4 |
| Metabolism and SWA | Correlation between SWA location, delirium subtype, and MCT2 expression. | Post-operative day 1 through 4 |
| Injury versus inflammation | Delayed resolution of biomarkers of neuronal dysfunction and inflammation as competing theories to neuronal injury. | 4 weeks prior to surgery to 1 year post-surgery |
| Neuronal injury - surgery type | Association between biomarkers of neuronal injury and type of surgery. | Post-operative day 1 through 4 |
| Change in cognition | Association of biomarkers of neuronal injury with change in cognition at 1 year. | Baseline to 1 year post-surgery |
| Change in cognition | Association of biomarkers of neuronal injury with change in cognition. | Post-operative day 1 through 4 |
| 40331035 | Derived | 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. |
| 37588271 | Derived | 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. |
| 37385855 | Derived | 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. |
| 36842841 | Derived | 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. |
| 36192219 | Derived | 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. |
| 35144802 | Derived | 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. |
| 34958346 | Derived | 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. |
| 33865555 | Derived | 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. |
| 33228978 | Derived | 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. |
| 32499013 | Derived | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |