Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change of Creatinine clearance from baseline
研究概览
简要总结
To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy
详细描述
A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of malignant tumor with peritoneal metastasis
- •Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy
排除标准
- •Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR < 30 mL/min/1.73m2)
- •Congestive heart failure
- •Atrioventricular block > 1st degree
- •Bradycardia < 45 beat per minute
- •History of myocardial infarction within 3 months
- •Pregnancy
研究组 & 干预措施
Dexmedetomidine
1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery
干预措施: Dexmedetomidine (Drug)
Normal Saline
IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change of Creatinine clearance from baseline
时间窗: Postoperative day 1,2,3,4,5,6,7
Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days
次要结局
未报告次要终点
研究者
Ji-young Kim
Associate Professor, Yonsei University Medical College
Gangnam Severance Hospital