Interventions for Postoperative Delirium: Biomarker-3

NCT ID: NCT03124303

Last Updated: 2025-12-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

468 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-13

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants 1-320

First 320 participants enrolled

High Density-Electroencephalogram

Intervention Type PROCEDURE

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

Magnetic Resonance Imaging

Intervention Type PROCEDURE

MRI scan of brain

Participants 321-470

Final 150 participants enrolled

High Density-Electroencephalogram

Intervention Type PROCEDURE

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

Magnetic Resonance Imaging

Intervention Type PROCEDURE

MRI scan of brain

Blood specimen collection

Intervention Type PROCEDURE

Blood will be collected from participants

Pupillometry

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type PROCEDURE

Magnetic Resonance Imaging

MRI scan of brain

Intervention Type PROCEDURE

Blood specimen collection

Blood will be collected from participants

Intervention Type PROCEDURE

Pupillometry

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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EEG MRI

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Kunkel, BS

Role: CONTACT

608-262-6469

Frankie Ingram, BS

Role: CONTACT

608-262-6469

Facility Contacts

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David Kunkel, BS

Role: primary

608-262-6469

Frankie Ingram, BS

Role: backup

608-262-6469

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.

Reference Type DERIVED
PMID: 40331035 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37588271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37385855 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36842841 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36192219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35144802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34958346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33865555 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33228978 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32499013 (View on PubMed)

Other Identifiers

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1K23AG055700-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AG063849-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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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