The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
研究概览
简要总结
Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.
The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.
The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
- •20 - 100 yrs old
排除标准
- •having preoperative severe renal dysfunction (eGFR < 15 ml/min per 1.73m2)
- •Left ventricular-ejection fraction < 30%
- •Preexisting congestive heart failure
- •Severe coronary artery disease
- •Hemodynamically unstable arrhythmia
- •Cardiogenic shock during perioperative period
- •Ventricular assist device use
- •cannot communication because of a language barrier or illiteracy
研究组 & 干预措施
dexmedetomidine
dexmedetomidine, 0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
干预措施: dexmedetomidine (Drug)
control
saline, same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
干预措施: saline (Drug)
结局指标
主要结局
Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)
时间窗: up to 7 days after the aortic surgery
0.3 mg/dl increase in serum creatinine concentration within 48 hours OR, a 50% increase within 7 days postoperatively OR, urine volume \< 0.5 ml/kg/h for 6 hours
次要结局
- major morbidity endpoint(acute kidney injury - up to 7 days after the surgery; Other - during the hospitalization for surgery)
- drug-related adverse events(hypotension or bradycardia: during surgery; Other - during surgery and 24 hours after surgery)
- postoperative delirium(up to 7 days after the surgery)
- Acute kidney injury (AKI) after aortic surgery (AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria)(up to 7 days after the surgery)