The Association Between Postoperative Inflammatory and Neuroogical Serum Biomarker Concentrations and Occurrence of Postoperative Delirium - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,170
- 试验地点
- 1
- 主要终点
- Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium
研究概览
简要总结
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days.
In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •≥ 65 years of age
- •Scheduled for elective major non-cardiac, non-intrcranial, non-vascular surgery with estimated time of surgery ≥ 2 hours
排除标准
- •Patients undergoing emergency surgery
- •History of diagnosed dementia
- •Language, vision, or hearing impairments that may compromise cognitive assessments
- •Preoperative delirium
- •ICU patients undergoing surgery
研究组 & 干预措施
Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery
干预措施: laboratory biomarker analysis (Diagnostic Test)
Patients aged ≥ 65 years scheduled for major non-cardiac, non-intracranial, non-vascular surgery
干预措施: 3D-CAM/CAM-ICU (Diagnostic Test)
结局指标
主要结局
Association between postoperative S100B, measured within two hours after surgery, and the incidence postoperative Delirium
时间窗: within three days after surgery
Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial three postoperative days while the patients remain hospitalized. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium. Blood will be drawn preoperatively and within two hours after the end of the surgery.
次要结局
- Association between postoperative NSE concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Association between postoperative IL-6 concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Association between postoperative Copeptin concentrations, measured within two hours after surgery, and the incidence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Predictive value of S100B concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Predictive value of NSE concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Predictive value of IL-6 concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
- Predictive value of Copeptin concentrations, within two hours after surgery, on the occurrence of postoperative delirium, assessed via 3D-CAM or CAM-ICU, within the first three postoperative days(within three days after surgery)
研究者
Christian Reiterer
Principal Investigator
Medical University of Vienna