Interventions for Postoperative Delirium: Biomarker-3

Delirium Clinical Trial

— IPOD-B3  

Official title:

Interventions for Postoperative Delirium: Biomarker-3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124303
• Other study ID #: 2015-0374
• Secondary ID: A530900SMPH\ANES
• Status: Recruiting
• Start date: February 13, 2017
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of Wisconsin, Madison
• Contact: David Kunkel, BS
• Phone: 608-262-6469
• Email: dkunkel[@]wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.

Description:

9/8/21-- Deleted two Outcome Measures pending IRB approval. 11/5/21-- added outcome measures after IRB approval.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years
• Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
• Written Informed Consent for potential participation prior to surgery

Exclusion Criteria:

• Contraindication to EEG
• Unable or unwilling to attend the follow-up appointments
• Documented history of dementia
• Deemed incapable of providing consent by surgical team
• Residing in a nursing home
• Undergoing intracranial surgery
• Unable to complete neurocognitive testing due to language, vision or hearing impairment
• Unable to communicate with the research staff due to language barriers
• For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Procedure:
• High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
• Magnetic Resonance Imaging
MRI scan of brain

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Connectivity	Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex	Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
Secondary	Inflammation	Assess the changes from preoperative to postoperative EEG associated with delirium and change in plasma/cerebrospinal fluid (CSF) IL-6 or other biomarkers (e.g. other cytokines or markers of neronal injury)	Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
Secondary	Biomarkers	Identify biomarkers of delirium and neural damage through changes in circulating plasma proteins and molecules (through mass spectometry)	Post-operative day 1 through 4
Secondary	Brain measurements	Assess the association between preoperative white matter connectivity (DTI) and cortical thickness (derived from MRI) and postoperative delirium	Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
Secondary	Long term cognition	Examine the incidence of delirium with change in cognition from preoperatively to one-year postoperatively.	Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Long term post-operative cognition measured 1 year after surgery.
Secondary	Long term cognition	Assess the impact of delirium, preoperative and postoperative imaging biomarkers with a change in long term cognition	Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
Secondary	Baseline cognition, specific and global.	Examine the association between preoperative cognition using a neuropsychological battery, and postoperative delirium incidence.	Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
Secondary	Biomarkers and brain measurements	Assess the changes in cognition and biomarkers over one year with EEG changes.	Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
Secondary	Representativeness of surgical population	Identify whether patients who consent to the MRI are reflective of the surgical population.	Pre-op MRI: up to 4 weeks prior to surgery.
Secondary	Genetics and delirium	Identify genetic and epigenetic changes associated with delirium and its pathogenesis.	Pre-op blood collected up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative blood collected on postoperative days 1-4. Long term blood collected 90 days and 1 year after surgery.
Secondary	Postoperative amyloid beta deposition and delirium	Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography at 90 days after surgery in sub-study IPOD-PET.	Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.
Secondary	Long term changes in amyloid beta deposition and delirium	Identify associations between delirium and amyloid beta deposition detected by Positron Emission Tomography preoperatively and 1 year after surgery in sub-study IPOD-PET2.	Pre-operative PET imaging will occur up to 4 weeks prior to surgery. Post-operative delirium measured on postoperative days 1-4. Post-operative PET imaging will occur 1 year after surgery.
Secondary	Long term cognition	Identify predictors of delirium severity and incidence, for change in cognition from preoperatively to two-years postoperatively.	Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.