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

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Enrolling

Conditions

Delirium

Treatments

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

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03124303
1R01AG063849-01 (U.S. NIH Grant/Contract)
1K23AG055700-01A1 (U.S. NIH Grant/Contract)
Protocol Version 1/15/25 (Other Identifier)
A530900 (Other Identifier)
SMPH\ANESTHESIOLOGY (Other Identifier)
2015-0374

Details and patient eligibility

About

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.

Enrollment

468 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

468 participants in 2 patient groups

Participants 1-320
Description:
First 320 participants enrolled
Treatment:
Procedure: Magnetic Resonance Imaging
Procedure: High Density-Electroencephalogram
Participants 321-470
Description:
Final 150 participants enrolled
Treatment:
Procedure: Blood specimen collection
Procedure: Magnetic Resonance Imaging
Diagnostic Test: Pupillometry
Procedure: High Density-Electroencephalogram

Trial contacts and locations

1

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Central trial contact

David Kunkel, BS; Frankie Ingram, BS

Data sourced from clinicaltrials.gov

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