NCT03124303招募中不适用
Interventions for Postoperative Delirium: Biomarker-3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Functional Connectivity
研究概览
简要总结
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.
详细描述
9/8/21-- Deleted two Outcome Measures pending IRB approval.
11/5/21-- added outcome measures after IRB approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1: Age ≥65 years
- •Cohort 2: Age ≥60 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
排除标准
- •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)
结局指标
主要结局
Functional Connectivity
时间窗: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex
Brain state change
时间窗: Post-operative day 1 through 4
Quantified by the MSD across regions of interest from resting state time-series to randomly spaced points across the time-series. Measured for Cohort 2 only.
次要结局
- Inflammation(Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: POD1-4)
- Biomarkers(Post-operative day 1 through 4)
- Brain measurements(Preoperative MRI will occur up to 4-weeks prior to surgery. Delirium is followed postoperatively, days 1-4)
- Long term cognition(Pre-operative cognition measures will occur up to 4 weeks prior to surgery. Long term post-operative cognition measured 2 years after surgery.)
- Baseline cognition, specific and global.(Cognition is assessed preoperatively. Participants are followed for delirium on postoperative days 1-4)
- Biomarkers and brain measurements(Pre-op measures: up to 4 weeks prior to surgery. Post-op measures: one year, and two years, after surgery.)
- Representativeness of surgical population(Pre-op MRI: up to 4 weeks prior to surgery.)
- Genetics and delirium(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.)
- Postoperative amyloid beta deposition and delirium(Post-operative delirium measured on postoperative days 1-4. PET imaging will occur 90 days after surgery.)
- Long term changes in amyloid beta deposition and delirium(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.)
- Mismatch negativity(Post-operative day 1 through 4)
- Resolution of slow wave activity(Post-operative day 1 through 4)
- Connectivity during delirium(Post-operative day 1 through 4)
- Effects of inflammation on brain activity(Post-operative day 1 through 4)
- Delirium subtypes - neuronal dynamics(Post-operative day 1 through 4)
- Delirium subtypes - predisposing neuronal dynamics(Up to 4 weeks prior to surgery.)
- Delirium subtypes - network stitching(Post-operative day 1 through 4)
- Delirium subtypes - network integration(Up to 4 weeks prior to surgery.)
- Pupillary responses(Post-operative day 1 through 4)
- Metabolism and SWA(Post-operative day 1 through 4)
- Injury versus inflammation(4 weeks prior to surgery to 1 year post-surgery)
- Neuronal injury - surgery type(Post-operative day 1 through 4)
- Change in cognition(Post-operative day 1 through 4)
研究者
研究点 (1)
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