Clinical trial NCT02926417: Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2)
Official title: Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective open thoracoabdominal aortic aneurysm or thoracic endovascular aortic/aneurysm repair surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
timeFrame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Secondary outcomes:
measure: Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period
timeFrame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
measure: Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients
timeFrame: Post-operative measure: Up to postoperative day (POD) 9
measure: Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative
timeFrame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
measure: Correlation of biomarkers with the incidence of spinal cord ischemia
timeFrame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin-Madison, School of Medicine and Public Health
name: Richard Lennertz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.