Protective Effect of Remote Ischemic Preconditioning (RIPC) Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- ∆SOFA
研究概览
简要总结
Remote ischaemic pre-conditioning (RIPC) has been recognized as a low-cost, non-invasive intervention method by applying brief ischaemia and reperfusion on an arm or a leg. Previous studies have mainly focused on the organoprotective effects of RIPC in patients undergoing cardiac surgery. However, whether it has an organ-protecting effect is still highly debated. We aimed to determine whether intensive RIPC can prevent from negative inflammatory response and organ dysfunction as well as postoperative complications in patients undergoing cardiovascular surgery.
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)
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
- •patients at high risk for organ dysfunctions who underwent elective cardiovascular surgery requiring cardiopulmonary bypass (CPB);
- •age of 18 -80 years old, regardless of gender;
- •subjects voluntarily participate in the trialand sign the informed consent;
排除标准
- •Arm fracture, skin injury or infection;
- •There is limb nerve injury;
- •Limb placement PICC, arteriovenous fistula and other devices that affect armband placement;
- •There are basic vascular lesions and poor blood supply at the extremities;
- •Limb thrombosis.
结局指标
主要结局
∆SOFA
时间窗: within the prior 7 days after cardiac surgery.
the change in sequential organ failure assessment score \[∆SOFA\]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score.
次要结局
- Plasma interleukin-1 levels(within the prior 7 days after cardiac surgery.)
研究者
Hong Liu
Principal Investigator of China 5A Network
Nanjing Medical University