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
- 1
- 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
研究组 & 干预措施
Control
干预措施: Control (Procedure)
Remote Ischemic Preconditioning (RIPC)
干预措施: RIPC (Procedure)
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
- Inflammation(72 hours)
- 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)
研究者
Christine Hsu
Principal Investigator
Seattle Children's Hospital