Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Neuroinflammation measured as IL-6 in CSF
研究概览
简要总结
The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.
详细描述
Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Health Class 1-4
- •Age 50-85 years
- •Fluent in Swedish language
- •Scheduled for primary hip replacement surgery due to arthrosis
- •MMSE (minimental state test score >= 25.
排除标准
- •Patient refusal to participate in the trial
- •Current autoimmune disease, including arthritis
- •Ongoing smoking, snuff or other nicotine compound treatment
- •Significant neurologic or psychiatric disorder (such as Alzheimer's disease, Parkinson's disease, Multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative MMSE score ≤ 24
- •History of stroke with neurological sequelae.
- •Current severe cardiac (NYHA>IV) or renal (plasma creatinine> 0.250 mmol/l) Coagulopathy making spinal anesthesia and intrathecal catheter placement impossible
- •Terminal phase of a chronic disease.
- •Patient on chronic steroidal therapy
- •Poorly controlled diabetes mellitus.
- •Presumed uncooperativeness or legal incapacity.
结局指标
主要结局
Neuroinflammation measured as IL-6 in CSF
时间窗: Up to 48 hours postoperatively
IL-6 in CSF
次要结局
- Peripheral inflammatory response(Up to 48 hours)
- Neuroinflammation(Up to 48 hours postoperatively)
- Cognitive function(Before surgery, within 7 days after surgery and 3 month after surgery)
研究者
Lars I Eriksson
Professor
Karolinska University Hospital