Hemofilters vs. Hemodialyzers: Impacts on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IL6 level as a proinflammatory cytokine
研究概览
简要总结
Cardiopulmonary bypass (CPB) allowed the correction of several congenital heart diseases such as intracardiac malformations, but it is well known that this is not a harmless procedure because it can lead to a systemic inflammatory response syndrome (SIRS), with activation of complement, cytokines, coagulation, and fibrinolysis pathways.
Due to economic causes, hemofilters became less available in low-resource countries, which forced perfusionists to use hemodialyzers instead during CPB. Preliminary data showed the potential safety of using hemodialyzers instead of hemofilters in Zero-balanced ultrafiltration.
The Objectives of the study This study aims to compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted.
- •Age of patients from 1 year to 15 years.
- •CPB duration more than 60 minutes.
排除标准
- •Pediatric patients with known signs of sepsis.
- •Pediatric patients having had previous cardiothoracic surgery.
- •Preoperative renal failure.
- •Preoperative cardiogenic shock requiring the use of inotropes.
- •Preoperative lactate concentration > 2 mmol/L.
研究组 & 干预措施
hemodialyzers
20 patients
干预措施: hemodializer (Device)
hemofilters
20 patients
干预措施: hemofilter (Device)
结局指标
主要结局
IL6 level as a proinflammatory cytokine
时间窗: preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).
次要结局
- Other proinflammatory cytokine(preoperatively after induction of anesthesia (T1), after removal of aorta cross clamp and before starting zero-balanced ultrafiltration (T2) and after coming off CPB (T3).)