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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02926417
Acronym
IPOD-B2
Enrollment
32
Registered
2016-10-06
Start date
2016-06-30
Completion date
2019-11-26
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

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.

Interventions

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changesPre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Secondary

MeasureTime frame
Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative periodPre-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 patientsPost-operative measure: Up to postoperative day (POD) 9
Absolute changes in activity and connectivity in HD-EEG from baseline to postoperativePre-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 ischemiaPre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026