Understanding brain activity and postoperative delirium in older patients
Interventions for Postoperative Delirium: Biomarker-3
This study is trying to see how brain activity before surgery affects the chances of older patients developing confusion after major surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 468 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT03124303 on ClinicalTrials.gov |
What this trial studies
The IPOD-B3 study investigates how premorbid brain activity relates to the occurrence of postoperative delirium in patients aged 60 and older undergoing major surgery. This observational study utilizes high-density electroencephalogram (EEG), magnetic resonance imaging (MRI), blood specimen collection, and pupillometry to gather data. By expanding on previous research, it aims to identify biomarkers that could predict delirium risk. Participants will be monitored during their hospital stay and followed up to assess cognitive outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 years and older who are scheduled for major surgery requiring at least a two-day hospital stay.
Not a fit: Patients with a documented history of dementia or those undergoing intracranial surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing postoperative delirium in older adults.
How similar studies have performed: Other studies have explored similar approaches to understanding delirium, but this specific investigation into premorbid brain activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Madison, Wisconsin
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Robert Pearce, MD, PhD — University of Wisconsin, Madison
- Study coordinator: David Kunkel, BS
- Email: dkunkel@wisc.edu
- Phone: 608-262-6469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.