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临床试验/NCT03170739
NCT03170739Unknown4 期

Effects of Dexmedetomidine and Dopamine on Renal Function After Selective Major Surgery in Adult Patients

Tao Zhang1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年6月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
180
试验地点
1
主要终点
Mortality

研究概览

简要总结

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure after major surgery. Dexmedetomidine is a highly selective alpha(2)-adreno receptor agonist widely used during anesthesia. In animals, dexmedetomidine has shown protective effects in AKI after surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output during surgery. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major surgery.

详细描述

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure in critically ill patients. AKI accounts for 5-10% after general surgery to 45% after cardiac surgery during hospital stays and tends to be associated with increased length of hospital stay as well as increased morbidity and mortality. Even slight increases in postoperative serum creatinine concentrations have been associated with almost 5-fold increases in mortality. Dexmedetomidine is a potent and highly selective alpha(2)-adreno receptor agonist that has analgesic, sedative, anxiolytic, and sympatholytic effects. In animals, dexmedetomidine has shown protective effects in several models of ischemia-reperfusion, which is thought to be the principal mechanism of AKI in the context of surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing selective major surgery

排除标准

  • Patients undergoing urologic surgery or neurosurgery
  • Patients with preoperative renal disorder

研究组 & 干预措施

Dexmedetomidine+dopamine

Experimental

Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine

Experimental

Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump at the beginning of surgery.

干预措施: Dexmedetomidine (Drug)

Dopamine

Experimental

Dopamine 3ug/kg/min ivpump at the beginning of surgery.

干预措施: Dopamine (Drug)

Dexmedetomidine+dopamine

Experimental

Dexmedetomidine 0.5ug/kg iv follow by 0.2ug/kg/h ivpump, combined with dopamine 3ug/kg/min ivpump at the beginning of surgery.

干预措施: Dopamine (Drug)

结局指标

主要结局

Mortality

时间窗: 30 days

Postoperative complications

时间窗: 2 weeks

Postoperative renal function

时间窗: Change from baseline to the 5th day after surgery

Serum Cr and Cys-c

次要结局

未报告次要终点

研究者

发起方
Tao Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tao Zhang

Clinical Professor of Department of Anesthesiology

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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