NCT03327389Unknown不适用
Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Serum creatinine level
研究概览
简要总结
The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
participants, investicator, outcome assessors will be blinded for group allocation.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (20-80 years old)
- •patients undergoing elective kidney transplantation
排除标准
- •emergency surgery
- •severe sinus bradycardia (<50 beats per min [bpm])
- •second-degree or third-degree heart block
- •decreased heart function (EF <30%)
- •acute myocardial ischemia
- •serious hepatic dysfunction (Child-Pugh class C)
- •patients with known or suspected severe adverse reactions to DEX (or clonidine)
- •treatment with clonidine or dexmedetomidine in the past 30 days
研究组 & 干预措施
Control (Group C)
Placebo Comparator
0.9% NaCl infusion during surgery 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure
干预措施: placebo (Drug)
Dexmedetomidine (Group D)
Experimental
Dexmedetomidine infusion during surgery Dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Serum creatinine level
时间窗: postoperative 7 day
次要结局
- blood urea nitrogen (BUN)(maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery)
- fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))(during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery)
- level of serum creatinine(maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery)
- Neutrophil gelatinase-associated lipocalin (NGAL)(maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery)
- urine output(during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery)
- incidence of delayed graft function(7 days after surgery)
- cystatin C(maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery)
- kidney ultrasound(1 week, 1 month after surgery, if possible)
- inflammatory mediator (IL-18, Il-1b) level(immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery)
研究者
研究点 (1)
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