The Use of Remote Ischemic Preconditioning Applied in Child the Day Before Open Heart Surgery With Extracorporeal Circulation to Correct Congenital Heart Diseases (the Second Window Effect)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- IkB-alpha Expression
研究概览
简要总结
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.
详细描述
Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).
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
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Month 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 month to 2 years age
- •waiting for open heart surgery in hospital
- •2008, january to march
- •Rachs-1, except the 1 category
排除标准
- •genetic syndromes
- •infected children
- •immunodeficiency
- •immunosuppressor use
- •no parents permission
结局指标
主要结局
IkB-alpha Expression
时间窗: 24 hours
Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.
Interleucine 8
时间窗: 24 hours
Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
次要结局
- NT-proBNP(24 hours)
- Troponin I(24 hours)
研究者
Marcos Alves Pavione
mester
University of Sao Paulo