IPOD-B3: Interventions for Postoperative Delirium: Biomarker-3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
9/8/21-- Deleted two Outcome Measures pending IRB approval.
11/5/21-- added outcome measures after IRB approval.
Study Design
Outcome Measures
Primary Outcome Measures
- Functional Connectivity [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
Secondary Outcome Measures
- Inflammation [Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4]
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)
- Biomarkers [Post-operative day 1 through 4]
Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry)
- Brain measurements [Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4]
Assess the association between preoperative white matter connectivity (DTI) and cortical thickness (derived from MRI) and postoperative delirium
- Long term cognition [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.]
Examine the incidence of delirium with change in cognition from preoperatively to one-year postoperatively.
- Long term cognition [Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery]
Assess the impact of delirium, preoperative and postoperative imaging biomarkers with a change in long term cognition
- Baseline cognition, specific and global. [Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4]
Examine the association between preoperative cognition using a neuropsychological battery, and postoperative delirium incidence.
- Biomarkers and brain measurements [Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.]
Assess the changes in cognition and biomarkers over one year with EEG changes.
- Representativeness of surgical population [Pre-op MRI: up to 4 weeks prior to surgery.]
Identify whether patients who consent to the MRI are reflective of the surgical population.
- 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.]
Identify genetic and epigenetic changes associated with delirium and its pathogenesis.
- Postoperative amyloid beta deposition and delirium [Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.]
Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography at 90 days after surgery in sub-study IPOD-PET.
- 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.]
Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography preoperatively and 1 year after surgery in sub-study IPOD-PET2.
- 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.]
Identify predictors of delirium severity and incidence, for change in cognition from preoperatively to two-years postoperatively.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥65 years
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Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
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Written Informed Consent for potential participation prior to surgery
Exclusion Criteria:
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Contraindication to MRI or EEG (e.g. implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still),
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Unable or unwilling to attend the follow-up appointments,
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Documented history of dementia
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Residing in a nursing home,
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Undergoing intracranial surgery
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Unable to complete neurocognitive testing due to language, vision or hearing impairment,
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Unable to communicate with the research staff due to language barriers,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin-Madison | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Robert Pearce, MD, PhD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-0374
- A530900
- SMPH\ANESTHESIOLOGY
- 1K23AG055700-01A1
- 1R01AG063849-01
- Protocol Version 8/1/2022