Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
研究概览
简要总结
The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
详细描述
In a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids.
30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood brain barrier function (alb).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective aortic surgery +/- coronary artery bypass grafting (CABG)
排除标准
- •coagulopathy
- •preoperative neurologic deficit
- •uncontrolled hypertension
研究组 & 干预措施
Methylprednisolone
Methylprednisolone i.v. 15mg/kg x 1 intraoperative Aortic Valve Replacement
干预措施: Methylprednisolone (Drug)
Placebo (NaCl)
Placebo i.v., x1, intraoperative Aortic Valve Replacement
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
时间窗: 24h after surgery
次要结局
- Postoperative/intraoperative insulin demand(24h after surgery)
研究者
Mattias Danielson
MD
Sahlgrenska University Hospital, Sweden