The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- serum creatinine
研究概览
简要总结
Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.
Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.
The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing congenital cardiac surgery
排除标准
- •history of allergy or anaphylaxis to study drug
- •preexisting renal dysfunction (preoperative creatinine >1.5mg/dl)
- •liver profile abnormality
研究组 & 干预措施
DEX
dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
no_DEX
Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.
干预措施: normal saline (Drug)
结局指标
主要结局
serum creatinine
时间窗: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
daily check the laboratory parameter.
次要结局
- glomerular filtration rate(immediate after surgery, until discharge from the ICU, assessed up to 1 week.)
- Urine output(immediate after surgery, until discharge from the ICU, assessed up to 1 week.)
研究者
Jin-Tae Kim
professor
Seoul National University Hospital