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 Type
OBSERVATIONAL
Enrollment
468
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
MRI scan of brain
Blood will be collected from participants
University of Wisconsin-Madison
Madison, Wisconsin, United States
RECRUITINGFunctional Connectivity
Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
Brain state change
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.
Time frame: Post-operative day 1 through 4
Inflammation
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)
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
Biomarkers
Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry)
Time frame: Post-operative day 1 through 4
Brain measurements
Assess the association between preoperative white matter connectivity (DTI) and cortical thickness (derived from MRI) and postoperative delirium
Time frame: Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
Long term cognition
Examine the incidence of delirium with change in cognition from preoperatively to one-year postoperatively.
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.
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A pupillometer is a device that measures the size of the pupils.
Long term cognition
Assess the impact of delirium, preoperative and postoperative imaging biomarkers with a change in long term cognition
Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
Baseline cognition, specific and global.
Examine the association between preoperative cognition using a neuropsychological battery, and postoperative delirium incidence.
Time frame: Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
Biomarkers and brain measurements
Assess the changes in cognition and biomarkers over one year with EEG changes.
Time frame: Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
Representativeness of surgical population
Identify whether patients who consent to the MRI are reflective of the surgical population.
Time frame: Pre-op MRI: up to 4 weeks prior to surgery.
Genetics and delirium
Identify genetic and epigenetic changes associated with delirium and its pathogenesis.
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.
Postoperative amyloid beta deposition and delirium
Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography at 90 days after surgery in sub-study IPOD-PET.
Time frame: 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
Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography preoperatively and 1 year after surgery in sub-study IPOD-PET2.
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.
Long term cognition
Identify predictors of delirium severity and incidence, for change in cognition from preoperatively to two-years postoperatively.
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.
Mismatch negativity
EEG mismatch negativity during delirium compared to resolution of delirium.
Time frame: Post-operative day 1 through 4
Resolution of slow wave activity
Slow wave activity during delirium compared to resolution of delirium.
Time frame: Post-operative day 1 through 4
Connectivity during delirium
Dynamic causal modeling of cortical connectivity during delirium.
Time frame: Post-operative day 1 through 4
Effects of inflammation on brain activity
EEG correlations with biomarkers of inflammation and neuronal injury.
Time frame: Post-operative day 1 through 4
Delirium subtypes - neuronal dynamics
EEG neuronal dynamics (energy landscape analysis) during hyperactive vs hypoactive delirium.
Time frame: Post-operative day 1 through 4
Delirium subtypes - predisposing neuronal dynamics
Preoperative neuronal dynamics between hyperactive and hypoactive delirium.
Time frame: Up to 4 weeks prior to surgery.
Delirium subtypes - network stitching
Task evoked network switching and locus coeruleus activity between hyperactive and hypoactive delirium.
Time frame: Post-operative day 1 through 4
Delirium subtypes - network integration
Preoperative brain network integration vs differentiation between hyperactive and hypoactive delirium.
Time frame: Up to 4 weeks prior to surgery.
Pupillary responses
Pupillary response during rest and cognitive task in delirious versus nondelirious participants.
Time frame: Post-operative day 1 through 4
Metabolism and SWA
Correlation between SWA location, delirium subtype, and MCT2 expression.
Time frame: Post-operative day 1 through 4
Injury versus inflammation
Delayed resolution of biomarkers of neuronal dysfunction and inflammation as competing theories to neuronal injury.
Time frame: 4 weeks prior to surgery to 1 year post-surgery
Neuronal injury - surgery type
Association between biomarkers of neuronal injury and type of surgery.
Time frame: Post-operative day 1 through 4
Change in cognition
Association of biomarkers of neuronal injury with change in cognition at 1 year.
Time frame: Baseline to 1 year post-surgery
Change in cognition
Association of biomarkers of neuronal injury with change in cognition.
Time frame: Post-operative day 1 through 4