Interventions for Postoperative Delirium: Biomarker-3 (IPOD-B3)

December 10, 2025 updated by: University of Wisconsin, Madison
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

9/8/21-- Deleted two Outcome Measures pending IRB approval.

11/5/21-- added outcome measures after IRB approval.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Pearce, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants 1-320
First 320 participants enrolled
Procedure: High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Other Names:
  • EEG
Procedure: Magnetic Resonance Imaging
MRI scan of brain
Other Names:
  • MRI
Participants 321-470
Final 150 participants enrolled
Procedure: High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
Other Names:
  • EEG
Procedure: Magnetic Resonance Imaging
MRI scan of brain
Other Names:
  • MRI
Procedure: Blood specimen collection
Blood will be collected from participants
Diagnostic test: Pupillometry
A pupillometer is a device that measures the size of the pupils.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
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.
Post-operative day 1 through 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammation
Time Frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
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
Biomarkers
Time Frame: Post-operative day 1 through 4
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
Time Frame: Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
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
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.
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
Time Frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
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.
Time Frame: Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
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
Time Frame: Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
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
Time Frame: Pre-op MRI: up to 4 weeks prior to surgery.
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
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.
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
Time Frame: Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.
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
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.
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
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.
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
Time Frame: Post-operative day 1 through 4
EEG mismatch negativity during delirium compared to resolution of delirium.
Post-operative day 1 through 4
Resolution of slow wave activity
Time Frame: Post-operative day 1 through 4
Slow wave activity during delirium compared to resolution of delirium.
Post-operative day 1 through 4
Connectivity during delirium
Time Frame: Post-operative day 1 through 4
Dynamic causal modeling of cortical connectivity during delirium.
Post-operative day 1 through 4
Effects of inflammation on brain activity
Time Frame: Post-operative day 1 through 4
EEG correlations with biomarkers of inflammation and neuronal injury.
Post-operative day 1 through 4
Delirium subtypes - neuronal dynamics
Time Frame: Post-operative day 1 through 4
EEG neuronal dynamics (energy landscape analysis) during hyperactive vs hypoactive delirium.
Post-operative day 1 through 4
Delirium subtypes - predisposing neuronal dynamics
Time Frame: Up to 4 weeks prior to surgery.
Preoperative neuronal dynamics between hyperactive and hypoactive delirium.
Up to 4 weeks prior to surgery.
Delirium subtypes - network stitching
Time Frame: Post-operative day 1 through 4
Task evoked network switching and locus coeruleus activity between hyperactive and hypoactive delirium.
Post-operative day 1 through 4
Delirium subtypes - network integration
Time Frame: Up to 4 weeks prior to surgery.
Preoperative brain network integration vs differentiation between hyperactive and hypoactive delirium.
Up to 4 weeks prior to surgery.
Pupillary responses
Time Frame: Post-operative day 1 through 4
Pupillary response during rest and cognitive task in delirious versus nondelirious participants.
Post-operative day 1 through 4
Metabolism and SWA
Time Frame: Post-operative day 1 through 4
Correlation between SWA location, delirium subtype, and MCT2 expression.
Post-operative day 1 through 4
Injury versus inflammation
Time Frame: 4 weeks prior to surgery to 1 year post-surgery
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
Time Frame: Post-operative day 1 through 4
Association between biomarkers of neuronal injury and type of surgery.
Post-operative day 1 through 4
Change in cognition
Time Frame: Baseline to 1 year post-surgery
Association of biomarkers of neuronal injury with change in cognition at 1 year.
Baseline to 1 year post-surgery
Change in cognition
Time Frame: Post-operative day 1 through 4
Association of biomarkers of neuronal injury with change in cognition.
Post-operative day 1 through 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Pearce, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-0374
  • A530900 (Other Identifier: UW Madison)
  • SMPH\ANESTHESIOLOGY (Other Identifier: UW Madison)
  • 1K23AG055700-01A1 (U.S. NIH Grant/Contract)
  • 1R01AG063849-01 (U.S. NIH Grant/Contract)
  • Protocol Version 1/15/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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