DeliriumIPOD-B3NCT03124303
Interventions for Postoperative Delirium: Biomarker-3
An observational study of Delirium, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- High Density-Electroencephalogram, Magnetic Resonance Imaging and Blood specimen collection
- Type of treatment
- Surgery or procedure
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53792
David Kunkel, BS, 608-262-6469, dkunkel@wisc.edu
Frankie Ingram, BS, 608-262-6469, fingram@wisc.edu
About this study
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.
- Conditions
- Delirium
- Being tested
- High Density-Electroencephalogram, Magnetic Resonance Imaging, Blood specimen collection, Pupillometry
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Density-ElectroencephalogramProcedure or surgery
Also called EEG
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Magnetic Resonance ImagingProcedure or surgery
Also called MRI
MRI scan of brain
Blood specimen collectionProcedure or surgery
Blood will be collected from participants
PupillometryDiagnostic test
A pupillometer is a device that measures the size of the pupils.
| Study group | Role | What they receive |
|---|---|---|
| Participants 1-320 | First 320 participants enrolled Receives: Procedure: High Density-Electroencephalogram; Procedure: Magnetic Resonance Imaging | |
| Participants 321-470 | Final 150 participants enrolled Receives: Procedure: High Density-Electroencephalogram; Procedure: Magnetic Resonance Imaging; Procedure: Blood specimen collection; Diagnostic Test: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity
Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex
Measured: 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.
Measured: Post-operative day 1 through 4
Secondary outcomes (26)
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)
Measured: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
Biomarkers
Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-op MRI: up to 4 weeks prior to surgery.
Genetics and delirium
Identify genetic and epigenetic changes associated with delirium and its pathogenesis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-operative day 1 through 4
Resolution of slow wave activity
Slow wave activity during delirium compared to resolution of delirium.
Measured: Post-operative day 1 through 4
Connectivity during delirium
Dynamic causal modeling of cortical connectivity during delirium.
Measured: Post-operative day 1 through 4
Effects of inflammation on brain activity
EEG correlations with biomarkers of inflammation and neuronal injury.
Measured: Post-operative day 1 through 4
Delirium subtypes - neuronal dynamics
EEG neuronal dynamics (energy landscape analysis) during hyperactive vs hypoactive delirium.
Measured: Post-operative day 1 through 4
Delirium subtypes - predisposing neuronal dynamics
Preoperative neuronal dynamics between hyperactive and hypoactive delirium.
Measured: Up to 4 weeks prior to surgery.
Delirium subtypes - network stitching
Task evoked network switching and locus coeruleus activity between hyperactive and hypoactive delirium.
Measured: Post-operative day 1 through 4
Delirium subtypes - network integration
Preoperative brain network integration vs differentiation between hyperactive and hypoactive delirium.
Measured: Up to 4 weeks prior to surgery.
Pupillary responses
Pupillary response during rest and cognitive task in delirious versus nondelirious participants.
Measured: Post-operative day 1 through 4
Metabolism and SWA
Correlation between SWA location, delirium subtype, and MCT2 expression.
Measured: Post-operative day 1 through 4
Injury versus inflammation
Delayed resolution of biomarkers of neuronal dysfunction and inflammation as competing theories to neuronal injury.
Measured: 4 weeks prior to surgery to 1 year post-surgery
Neuronal injury - surgery type
Association between biomarkers of neuronal injury and type of surgery.
Measured: Post-operative day 1 through 4
Change in cognition
Association of biomarkers of neuronal injury with change in cognition at 1 year.
Measured: Baseline to 1 year post-surgery
Change in cognition
Association of biomarkers of neuronal injury with change in cognition.
Measured: Post-operative day 1 through 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start13 Feb 2017
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Robert Pearce, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124303
- Sponsor's protocol ID
- 2015-0374
- Other IDs
- 1K23AG055700-01A1, 1R01AG063849-01, A530900, SMPH\ANESTHESIOLOGY, Protocol Version 1/15/25
- Acronym
- IPOD-B3
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2017
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42145626Taylor 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.
PubMed 41475933Rivera 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.
PubMed 40331035Kunkel 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.
PubMed 37588271Taylor 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.
PubMed 37385855Payne 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.
PubMed 36842841Taylor 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.
PubMed 36192219Taylor 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.
PubMed 35144802Tanabe 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.
PubMed 34958346White 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.
PubMed 33865555Ballweg 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.
PubMed 33228978Tanabe 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.
PubMed 32499013
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Postoperative Delirium: Biomarker-3
- ClinicalTrials.gov ID
- NCT03124303
- Acronym / sponsor ID
- IPOD-B3 / 2015-0374
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants 1-320 | – | Procedure: High Density-Electroencephalogram, Procedure: Magnetic Resonance ImagingFirst 320 participants enrolled |
| Participants 321-470 | – | Procedure: High Density-Electroencephalogram, Procedure: Magnetic Resonance Imaging, Procedure: Blood specimen collection, Diagnostic Test: PupillometryFinal 150 participants enrolled |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Density-ElectroencephalogramAlso: EEGEEG is a safe non-invasive technology without complications that may be used to help diagnose delirium | Procedure or surgery | Participants 1-320, Participants 321-470 |
| Magnetic Resonance ImagingAlso: MRIMRI scan of brain | Procedure or surgery | Participants 1-320, Participants 321-470 |
| Blood specimen collectionBlood will be collected from participants | Procedure or surgery | Participants 321-470 |
| PupillometryA pupillometer is a device that measures the size of the pupils. | Diagnostic test | Participants 321-470 |
Primary outcome
Functional Connectivity
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex
Brain state change
Time frame: Post-operative day 1 through 4
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.
26 secondary outcomes
Inflammation
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
Biomarkers
Time frame: Post-operative day 1 through 4
Brain measurements
Time frame: Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
Long term cognition
Time frame: 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
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
Baseline cognition, specific and global.
Time frame: Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
Biomarkers and brain measurements
Time frame: Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
Representativeness of surgical population
Time frame: Pre-op MRI: up to 4 weeks prior to surgery.
Genetics and delirium
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post-operative day 1 through 4
Resolution of slow wave activity
Time frame: Post-operative day 1 through 4
Connectivity during delirium
Time frame: Post-operative day 1 through 4
Effects of inflammation on brain activity
Time frame: Post-operative day 1 through 4
Delirium subtypes - neuronal dynamics
Time frame: Post-operative day 1 through 4
Delirium subtypes - predisposing neuronal dynamics
Time frame: Up to 4 weeks prior to surgery.
Delirium subtypes - network stitching
Time frame: Post-operative day 1 through 4
Delirium subtypes - network integration
Time frame: Up to 4 weeks prior to surgery.
Pupillary responses
Time frame: Post-operative day 1 through 4
Metabolism and SWA
Time frame: Post-operative day 1 through 4
Injury versus inflammation
Time frame: 4 weeks prior to surgery to 1 year post-surgery
Neuronal injury - surgery type
Time frame: Post-operative day 1 through 4
Change in cognition
Time frame: Baseline to 1 year post-surgery
Change in cognition
Time frame: Post-operative day 1 through 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 42145626Lv 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.
- Derived from this study: PubMed 41475933Taylor 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.
- Derived from this study: PubMed 40331035Rivera 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.
- Derived from this study: PubMed 37588271Kunkel 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.
- Derived from this study: PubMed 37385855Taylor 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.
- Derived from this study: PubMed 36842841Payne 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.
- Derived from this study: PubMed 36192219Taylor 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.
- Derived from this study: PubMed 35144802Taylor 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.
- Derived from this study: PubMed 34958346Tanabe 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.
- Derived from this study: PubMed 33865555White 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.
- Derived from this study: PubMed 33228978Ballweg 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.
- Derived from this study: PubMed 32499013Tanabe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Pearce, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Kunkel, BS (608-262-6469, dkunkel@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Connectivity (time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124303, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.