Acute Kidney Injury in Children Operated for Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Acute kidney injury
研究概览
简要总结
The purpose of this study was to investigate if repeated inflation of a blood pressure cuff applied around one leg causing mild ischemia ("remote ischemic preconditioning") could protect children operated for congenital heart disease from developing acute kidney injury.
详细描述
Remote ischemic preconditioning (RIPC) refers to an intervention of remote, brief ischemia which confers systemic protection against consequences of reperfusion injury in distant organs. RIPC has been shown to protect various organs during major surgeries. Our hypothesis was that RIPC could protect kidney function in children operated for complex congenital heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children admitted for surgery for congenital heart disease
排除标准
- •heart surgeries of low complexity such as closure of septal defects, aortico-pulmonary windows, establishment of glenn shunts, subaortic membrane resection, redirection of anomalous pulmonary veins, valvotomies, repair of pulmonary artery stenosis and surgeries without the use of extracorporeal circulation
结局指标
主要结局
Acute kidney injury
时间窗: Up to 4 days
Categorized according to the RIFLE criteria (22): R= risk= increased p-creatinine \* 1.5 and/or urine output \< 0.5 ml/kg/hour for 6 hours, I= injury= increased p-creatinine \* 2 and/or urine output \< 0.5 ml/kg/hour for 12 hours, F= failure= increased p-creatinine \* 3 or p-creatinine ≥ 350 µmol/L in the setting of an acute increase of at least 44 µmol/L and/or urine output \< 0.3 ml/kg/hour for 24 hours or anuria for 12 hours, L= complete loss of renal function for \> 4 weeks (need for dialysis for longer than 4 weeks), E= end-stage renal disease (need for dialysis for longer than 3 months).
次要结局
- Arterial blood pressure(Up to 3 days)
- Inotropic Score (IS)(Up to 3 days)
- Reoperation during hospital stay(90 days)
- Length of stay at the ICU(90 days)
- Length of hospital stay(90 days)
- Mortality(90 days)
- Level of cystatin C in plasma(Up to 4 days)
- Level of Neutrophil Gelatinase-Associated Lipocalin in plasma and urine(Up to 4 days)