The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- COx
研究概览
简要总结
Investigating the connection between delivered oxygen index and cerebral impact with COx (cerebral oximetry index) och cerebral injury markers during the routine use of cardiopulmonary bypass.
详细描述
The research subjects are to be treated with CPB with according to local standards (perfusion index 2.4 x body surface area). While measuring impact on cerebral autoregulation with the aid of Near InfraRed Spectroscopy (NIRS) and brain injury markers in blood, research subjects depending on initial hemoglobin value, will divide into two subgroups: one with DO2I of >280 ml/min/m2, and one with DO2I of <280 ml/min/m2.
DO2I will during CPB be calculated using the patient data monitoring system Metavision.
With a correlation analysis between NIRS and MAP (mean arterial pressure) a COx (Cerebral Oxymetry Index) r-value can indicate impact on cerebral autoregulation with values >0.3 - 0.5 during use of CPB 4.
Brain injury markers (Tau, Glial Fibrillary Acidic Protein (GFAP), Neurospecific Enolase (NSE)) are collected during 5 occasions during the first 24 hours and then once per day for 4 days, as well as markers for AKI (S-Creatinine) in some extent.
Registrations during the intensive care regarding delirium, stroke or other neurological impact will also be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for CABG and/or AVR
排除标准
- •Former diagnosed neurological insults, carotid stenosis
结局指标
主要结局
COx
时间窗: 24 hours
COx (Cerebral Oximetry Index; correlation between rSO2 values (INVOS) and mean artery pressure) that indicated impact on cerebral autoregulation on DO2 index values below set limits of 280 ml/m2/min.
Brain injury markers; tau, GFAP, NSE
时间窗: 96 hours
Brain injury markers that indicate cerebral neuronal damage on DO2 index values below set limits of 280 ml/m2/min.
次要结局
未报告次要终点