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

Completed

• Conditions: Delirium

• Registration Number: NCT02926417
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes	Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States