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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03124303




Registration number
NCT03124303
Ethics application status
Date submitted
29/03/2017
Date registered
21/04/2017
Date last updated
27/06/2024

Titles & IDs
Public title
Interventions for Postoperative Delirium: Biomarker-3
Scientific title
Interventions for Postoperative Delirium: Biomarker-3
Secondary ID [1] 0 0
A530900
Secondary ID [2] 0 0
2015-0374
Universal Trial Number (UTN)
Trial acronym
IPOD-B3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1316
Treatment: Surgery - High Density-Electroencephalogram
Treatment: Surgery - Magnetic Resonance Imaging

Treatment: Drugs: SHR-1316
PD-L1

Treatment: Surgery: High Density-Electroencephalogram
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium

Treatment: Surgery: Magnetic Resonance Imaging
MRI scan of brain
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Functional Connectivity
Timepoint [1] 0 0
Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
Secondary outcome [1] 0 0
Inflammation
Timepoint [1] 0 0
Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4
Secondary outcome [2] 0 0
Biomarkers
Timepoint [2] 0 0
Post-operative day 1 through 4
Secondary outcome [3] 0 0
Brain measurements
Timepoint [3] 0 0
Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4
Secondary outcome [4] 0 0
Long term cognition
Timepoint [4] 0 0
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 outcome [5] 0 0
Long term cognition
Timepoint [5] 0 0
Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to two years after surgery
Secondary outcome [6] 0 0
Baseline cognition, specific and global.
Timepoint [6] 0 0
Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4
Secondary outcome [7] 0 0
Biomarkers and brain measurements
Timepoint [7] 0 0
Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.
Secondary outcome [8] 0 0
Representativeness of surgical population
Timepoint [8] 0 0
Pre-op MRI: up to 4 weeks prior to surgery.
Secondary outcome [9] 0 0
Genetics and delirium
Timepoint [9] 0 0
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 outcome [10] 0 0
Postoperative amyloid beta deposition and delirium
Timepoint [10] 0 0
Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.
Secondary outcome [11] 0 0
Long term changes in amyloid beta deposition and delirium
Timepoint [11] 0 0
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 outcome [12] 0 0
Long term cognition
Timepoint [12] 0 0
Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03124303
Trial related presentations / publications
Taylor J, Payne T, Casey C, Kunkel D, Parker M, Rivera C, Zetterberg H, Blennow K, Pearce RA, Lennertz RC, McCulloch T, Gaskell A, Sanders RD. Sevoflurane dose and postoperative delirium: a prospective cohort analysis. Br J Anaesth. 2023 Feb;130(2):e289-e297. doi: 10.1016/j.bja.2022.08.022. Epub 2022 Oct 1.
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.
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Robert Pearce, MD, PhD
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Kunkel, BS
Address 0 0
Country 0 0
Phone 0 0
608-262-6469
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03124303