NCT02926417已完成不适用
Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
研究概览
简要总结
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.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (>21 years old)
- •Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair)
- •Requiring spinal drain for surgery that is predicted to stay in two or more days
- •Willing and able to provide informed consent
排除标准
- •Contraindication for spinal drain
- •Documented history of dementia
- •Unable to communicate with the research staff due to language barriers
- •Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations.
- •Pregnant or Nursing
结局指标
主要结局
Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes
时间窗: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9
次要结局
- 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)
- 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)
- 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)
- Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients(Post-operative measure: Up to postoperative day (POD) 9)
研究者
研究点 (1)
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