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

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.

Full Title of Study: “Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 26, 2019

Interventions

  • Procedure: High Density-Electroencephalogram

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Lennertz, MD PhD, Principal Investigator, University of Wisconsin-Madison, School of Medicine and Public Health

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