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

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

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 Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Procedure: High Density-Electroencephalogram

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective open thoracoabdominal aortic aneurysm or thoracic endovascular aortic/aneurysm repair surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Richard Lennertz, MD PhD, University of Wisconsin-Madison, School of Medicine and Public Health

Publications and helpful links

General Publications

• Taylor J, Parker M, Casey CP, Tanabe S, Kunkel D, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, Sanders RD. Postoperative delirium and changes in the blood-brain barrier, neuroinflammation, and cerebrospinal fluid lactate: a prospective cohort study. Br J Anaesth. 2022 Aug;129(2):219-230. doi: 10.1016/j.bja.2022.01.005. Epub 2022 Feb 8.
• Tanabe S, Parker M, Lennertz R, Pearce RA, Banks MI, Sanders RD. Reduced Electroencephalogram Complexity in Postoperative Delirium. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):502-506. doi: 10.1093/gerona/glab352.
• Parker M, White M, Casey C, Kunkel D, Bo A, Blennow K, Zetterberg H, Pearce RA, Lennertz R, Sanders RD. Cohort Analysis of the Association of Delirium Severity With Cerebrospinal Fluid Amyloid-Tau-Neurodegeneration Pathologies. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):494-501. doi: 10.1093/gerona/glab203.
• Ballweg T, White M, Parker M, Casey C, Bo A, Farahbakhsh Z, Kayser A, Blair A, Lindroth H, Pearce RA, Blennow K, Zetterberg H, Lennertz R, Sanders RD. Association between plasma tau and postoperative delirium incidence and severity: a prospective observational study. Br J Anaesth. 2021 Feb;126(2):458-466. doi: 10.1016/j.bja.2020.08.061. Epub 2020 Nov 20.
• Tanabe S, Mohanty R, Lindroth H, Casey C, Ballweg T, Farahbakhsh Z, Krause B, Prabhakaran V, Banks MI, Sanders RD. Cohort study into the neural correlates of postoperative delirium: the role of connectivity and slow-wave activity. Br J Anaesth. 2020 Jul;125(1):55-66. doi: 10.1016/j.bja.2020.02.027. Epub 2020 Jun 1.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): November 26, 2019

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2015-0960; A530900 (Other Identifier: UW Madison); SMPH/ANESTHESIOLOGY/ANESTHESIO (Other Identifier: UW Madison); Protocol Version 4/20/2020 (Other Identifier: UW Madison)