Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in lactate level of the lactated ringer group compared to the normal saline group
研究概览
简要总结
Lactated Ringer(LR) has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. However, the utility of LR in pediatric with hepatic failure undergoing liver transplantation is unclear, because addition of exogenous lactate may increase lactate concentration. In addition,large amounts of normal saline(NS) which does not contain lactate can induce a hyperchloremic metabolic acidosis and have been asociated with adverse effects on kidney injury, coagulation, and death. Accordingly, the investigators performed a double-blinded randomized trial comparing the effects of intraoperative NS or LR on outcomes in pediatric receiving Liver transplantation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients between the age of 3 month and 6 years
- •Scheduled for living donor liver transplantation
排除标准
- •Re-transplantation
- •Combined liver and kidney transplantation
- •Congenital heart disease
- •Refused to participate the study
研究组 & 干预措施
Lactated ringers solution
Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
干预措施: Lactated Ringer (Drug)
Normal saline solution
Participants in this group will receive Normal saline solution during the intraoperative period.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in lactate level of the lactated ringer group compared to the normal saline group
时间窗: up to 3 days after surgery
Baseline serum lactate will be measured after randomization and again after surgery, then every 24 hours for 72 hours
次要结局
- Length of mechanical ventilation(up to 30 days after surgery)
- 30 day mortality(up to 30 days after surgery)
- ICU stay(up to 30 days after surgery)