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Recruiting NCT03124303

NCT03124303 Interventions for Postoperative Delirium: Biomarker-3

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Clinical Trial Summary
NCT ID NCT03124303
Status Recruiting
Phase
Sponsor University of Wisconsin, Madison
Condition Delirium
Study Type OBSERVATIONAL
Enrollment 468 participants
Start Date 2017-02-13
Primary Completion 2029-12

Eligibility & Interventions

Sex All sexes
Min Age 60 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
High Density-ElectroencephalogramMagnetic Resonance ImagingBlood specimen collection

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 468 participants in total. It began in 2017-02-13 with a primary completion date of 2029-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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)

Contact & Investigator

Central Contact

David Kunkel, BS

✉ dkunkel@wisc.edu

📞 608-262-6469

Principal Investigator

Robert Pearce, MD, PhD

PRINCIPAL INVESTIGATOR

University of Wisconsin, Madison

Frequently Asked Questions

Who can join the NCT03124303 clinical trial?

This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03124303 currently recruiting?

Yes, NCT03124303 is actively recruiting participants. Contact the research team at dkunkel@wisc.edu for enrollment information.

Where is the NCT03124303 trial being conducted?

This trial is being conducted at Madison, United States.

Who is sponsoring the NCT03124303 clinical trial?

NCT03124303 is sponsored by University of Wisconsin, Madison. The principal investigator is Robert Pearce, MD, PhD at University of Wisconsin, Madison. The trial plans to enroll 468 participants.

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