Interventions for Postoperative Delirium: Biomarker-3

NCT03124303 | Recruiting

• 6 other identifiers: 2015-03741K23AG055700-01A11R01AG063849-01A530900SMPH\ANESTHESIOLOGYProtocol Version 1/15/25
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (26)

• Inflammation

  Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4

• Biomarkers

  Post-operative day 1 through 4

• Brain measurements

  Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4

• Long term cognition

  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

  Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery

Study Arms (2)

Participants 1-320

First 320 participants enrolled

Procedure: High Density-Electroencephalogram; Procedure: Magnetic Resonance Imaging

Participants 321-470

Final 150 participants enrolled

Procedure: High Density-Electroencephalogram; Procedure: Magnetic Resonance Imaging; Procedure: Blood specimen collection; Diagnostic Test: Pupillometry

Interventions

High Density-Electroencephalogram PROCEDURE

EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium

Also known as: EEG

Participants 1-320; Participants 321-470

Magnetic Resonance Imaging PROCEDURE

MRI scan of brain

Also known as: MRI

Participants 1-320; Participants 321-470

Blood specimen collection PROCEDURE

Blood will be collected from participants

Participants 321-470

Pupillometry DIAGNOSTIC_TEST

A pupillometer is a device that measures the size of the pupils.

Participants 321-470

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (11)

• 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. 2025 Dec 30:S0007-0912(25)00844-X. doi: 10.1016/j.bja.2025.11.036. Online ahead of print.

  PMID: 41475933 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.

  PMID: 40331035 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.

  PMID: 37588271 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.

  PMID: 37385855 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.

  PMID: 36842841 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.

  PMID: 36192219 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.

  PMID: 35144802 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.

  PMID: 34958346 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.

  PMID: 33865555 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.

  PMID: 33228978 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.

  PMID: 32499013 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Participant blood and cerebrospinal fluid (CSF) will be collected and stored for future analysis.

MeSH Terms

Conditions

Delirium

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Robert Pearce, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Kunkel, BS

CONTACT

608-262-6469; dkunkel@wisc.edu

Frankie Ingram, BS

CONTACT

608-262-6469; fingram@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 21, 2017
• Study Start: February 13, 2017
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)