Interventions for Postoperative Delirium: Biomarker-3

University of Wisconsin, Madison1 site in 1 country468 target enrollmentFebruary 13, 2017

ConditionsDelirium

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Delirium
Sponsor: University of Wisconsin, Madison
Enrollment: 468
Locations: 1
Primary Endpoint: Functional Connectivity
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

9/8/21-- Deleted two Outcome Measures pending IRB approval. 11/5/21-- added outcome measures after IRB approval.

Registry

clinicaltrials.gov

Start Date

February 13, 2017

End Date

December 1, 2029

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

Inflammation(Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4)
Biomarkers(Post-operative day 1 through 4)
Brain measurements(Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4)
Long term cognition(Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.)
Baseline cognition, specific and global.(Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4)
Biomarkers and brain measurements(Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.)
Representativeness of surgical population(Pre-op MRI: up to 4 weeks prior to surgery.)
Genetics and delirium(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(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(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.)
Mismatch negativity(Post-operative day 1 through 4)
Resolution of slow wave activity(Post-operative day 1 through 4)
Connectivity during delirium(Post-operative day 1 through 4)
Effects of inflammation on brain activity(Post-operative day 1 through 4)
Delirium subtypes - neuronal dynamics(Post-operative day 1 through 4)
Delirium subtypes - predisposing neuronal dynamics(Up to 4 weeks prior to surgery.)
Delirium subtypes - network stitching(Post-operative day 1 through 4)
Delirium subtypes - network integration(Up to 4 weeks prior to surgery.)
Pupillary responses(Post-operative day 1 through 4)
Metabolism and SWA(Post-operative day 1 through 4)
Injury versus inflammation(4 weeks prior to surgery to 1 year post-surgery)
Neuronal injury - surgery type(Post-operative day 1 through 4)
Change in cognition(Post-operative day 1 through 4)