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

University of Wisconsin, Madison1 site in 1 country32 target enrollmentJune 2016

ConditionsDelirium

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Delirium
Sponsor: University of Wisconsin, Madison
Enrollment: 32
Locations: 1
Primary Endpoint: Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

November 26, 2019

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult (\>21 years old)
•Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair)
•Requiring spinal drain for surgery that is predicted to stay in two or more days
•Willing and able to provide informed consent

Exclusion Criteria

•Contraindication for spinal drain
•Documented history of dementia
•Unable to communicate with the research staff due to language barriers
•Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations.
•Pregnant or Nursing

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

Correlation of biomarkers with the incidence of spinal cord ischemia(Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9)
Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative(Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9)
Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period(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(Post-operative measure: Up to postoperative day (POD) 9)