Effects of Remote Ischaemic Preconditioning in Cemented Total Hip Arthroplasty: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Myocardial injury
研究概览
简要总结
Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
详细描述
Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Cemented hip arthroplasty is strongly associated with bone cement implantation syndrome (BCIS). It is characterized by hypoxia, hypotension and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion or reduction of the joint. It has been shown to increase cardiovascular and renal complication and brain damage postoperatively. Remote-ischemic preconditioning has shown kidney, myocardial and brain injury protective effect on non-cardiac surgery patients. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention.
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >65 years
- •undergoing total hip cemented hip arthroplasty
排除标准
- •previously diagnosed peripheral artery disease on both upper limb
- •RIPC is contraindicated
结局指标
主要结局
Myocardial injury
时间窗: From enrollment to 3. postoperative day
Peak hs-cTnT value * baseline characteristics are measured before surgery * measuring is repeated 1h after surgery and up to 3 days postoperatively
次要结局
- Total antioxidative capacity (TAC)(From enrollment to 3. postoperative day)
- Cardiovascular injury(From enrollment to 3. postoperative day)
- Kidney Injury(From enrollment to 3. postoperative day)
- Clinical serious complications(From enrollment to 1 year postoperatively)
- Carotid-femoral pulse velocity(From enrollment to 1. postoperative day)
- Oxidative stress level (total peroxide levels)(From enrollment to 3. postoperative day)
- Augmentation index(From enrollment to 1. postoperative day)
- Brain injury(From enrollment to 3. postoperative day)
- Inflammation level(From enrollment to 3. postoperative day)
- Low molecular weight metabolites (uM)(From enrollment to 1. postoperative day)
研究者
Kaspar Tootsi
Principal Investigator
University of Tartu