The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- IL-6 and IL-8 2 hours post CPB
研究概览
简要总结
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
详细描述
After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.
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
- Double
入排标准
- 年龄范围
- — 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
- •Age below 17 weeks
排除标准
- •Preoperative: organ failure (other than heart), serum sodium > 155 mmol/l, central venous pressure > 12 mmHg
- •Perioperative: core temperature < 25 ºC on CPB, re-heparinization, re-operation
结局指标
主要结局
IL-6 and IL-8 2 hours post CPB
Extra vascular lung water 2 and 24 hours post CPB
次要结局
- Fluid balance
- Weight gain
- Cardiac output
- Intrathorasic blood volume
- Blood pressure during the first 24 hours post CPB