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

NCT02926417 | Completed DMC

• 4 other identifiers: 2015-0960A530900SMPH/ANESTHESIOLOGY/ANESTHESIOProtocol Version 4/20/2020
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

High Density-Electroencephalogram PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Prisoners

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (5)

• 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.

  PMID: 35144802 DERIVED

• 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.

  PMID: 34958346 DERIVED

• 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.

  PMID: 34260706 DERIVED

• 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.

  PMID: 33228978 DERIVED

• 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.

  PMID: 32499013 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participant blood and cerebral spinal fluid samples will be collected and stored for future analysis.

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Richard Lennertz, MD PhD

  University of Wisconsin-Madison, School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: October 6, 2016
• Study Start: June 1, 2016
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)