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

Delirium Clinical Trial

— IPOD-B2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926417
• Other study ID #: 2015-0960
• Secondary ID: A530900SMPH/ANES
• Status: Completed
• Start date: June 2016
• Est. completion date: November 26, 2019

Study information

• Verified date: October 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Procedure:
• High Density-Electroencephalogram

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients		Post-operative measure: Up to postoperative day (POD) 9
Secondary	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
Secondary	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