The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.
详细描述
The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged less than 7 years old
- •American Society of Anesthesiology (ASA) physical status 1-3
排除标准
- •Preoperative creatinine > 1.5mg/dl
- •History of dialysis
- •Liver function abnormality
- •Diabetes Mellitus
- •History of allergic reaction
- •Coagulation abnormality
研究组 & 干预措施
Crystalloid group
Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.
干预措施: Crystalloid (Drug)
Colloid group
Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.
干预措施: Colloid (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: From the day of surgery to postoperative 7 days
次要结局
- Blood loss(From the day of surgery to postoperative 7 days)
- Length of ICU stay(From the day of surgery to postoperative 7 days)
- Transfusion amount(From the day of surgery to postoperative 7 days)
- Mechanical ventilation time(From the day of surgery to postoperative 7 days)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital