Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2)

University of Wisconsin, Madison32 enrolled

Overview

The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Delirium

Interventions

High Density-ElectroencephalogramPROCEDURE

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult (\>21 years old) 2. Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair) 3. Requiring spinal drain for surgery that is predicted to stay in two or more days 4. Willing and able to provide informed consent Exclusion Criteria: 1. Contraindication for spinal drain 2. Documented history of dementia 3. Unable to communicate with the research staff due to language barriers 4. Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations. 5. Pregnant or Nursing 6. Prisoners

Locations (1)

University of Wisconsin-Madison

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes

Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Secondary Outcomes

Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period

Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients

Time frame: Post-operative measure: Up to postoperative day (POD) 9

Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative

Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Correlation of biomarkers with the incidence of spinal cord ischemia

Time frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Data from ClinicalTrials.gov

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