Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Incidence of acute kidney injury (AKI)
研究概览
简要总结
Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.
详细描述
In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass
排除标准
- •Any contraindication to compression of lower extremity/extremities Body weight <2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery
结局指标
主要结局
Incidence of acute kidney injury (AKI)
时间窗: 72 hours
Serum creatinine (SCr) will be measured at baseline, then on post-operative days 1, 2, and 3.
Incidence of acute myocardial injury
时间窗: 48 hours
Troponin-I will be measured at baseline, then 6, 12, 24, and 48 hours post-operative.
次要结局
- Biomarkers for AKI(72 hours)
- Incidence of acute lung injury(72 hours and duration of hospitalization)
- Mortality(Duration of hospitalization, 30 days post-op, and at last follow-up)
- Hospitalization(Duration of post-operative hospitalization)
- Inflammation(72 hours)
研究者
Christine Hsu
Principal Investigator
Seattle Children's Hospital