NCT01886079Unknown4 期
The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:
研究概览
简要总结
The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients over the age of 20 scheduled for valvular heart surgery
排除标准
- •Left ventricular-ejection fraction < 30%
- •Preexisting congestive heart failure
- •Severe coronary artery disease
- •Hemodynamically unstable arrhythmia
- •Cardiogenic shock during perioperative period
- •Ventricular assist device
- •Severe renal dysfunction (eGFR < 15ml/min per 1.73m2)
研究组 & 干预措施
Dexmedetomidine group
Experimental
干预措施: dexmedetomidine (Drug)
Saline group
Placebo Comparator
干预措施: Saline (Drug)
结局指标
主要结局
Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:
时间窗: 24 hours after surgery.
BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)
次要结局
未报告次要终点
研究者
研究点 (1)
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