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

NCT ID: NCT02926417

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-11-26

Brief Summary

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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

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Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High Density-Electroencephalogram

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lennertz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35144802 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34958346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34260706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33228978 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32499013 (View on PubMed)

Other Identifiers

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A530900

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/ANESTHESIOLOGY/ANESTHESIO

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/20/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0960

Identifier Type: -

Identifier Source: org_study_id