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Completed

NCT Number: NCT02926417

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High Density-Electroencephalogram

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients

    Time frame: Post-operative measure: Up to postoperative day (POD) 9

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: IPOD-B2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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