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临床试验/NCT01369732
NCT01369732已完成4 期

Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Incidence of Acute Kidney Injury Based on RIFLE Criteria

研究概览

简要总结

During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.

However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults above age of 20
  • Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest

排除标准

  • pregnancy or lactation
  • cerebrovascular thrombosis
  • past history of pulmonary embolism or thrombosis
  • past history of thoracic aortic surgery
  • preoperative acute kidney injury
  • chronic renal replacement therapy
  • allergy or hypersensitivity to erythropoetin
  • history of erythropoetin treatment
  • death during or one day after surgery
  • reoperation within seven days of the first surgery

研究组 & 干预措施

Saline group

Placebo Comparator

We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.

干预措施: saline (Drug)

erythropoietin group

Experimental

We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.

干预措施: recombinant human erythropoietin (Drug)

结局指标

主要结局

Incidence of Acute Kidney Injury Based on RIFLE Criteria

时间窗: upto 7 days after surgery

次要结局

  • the Duration of ICU Stay(upto 2 weeks after surgery)
  • Mortality(upto 1 month after surgery)
  • the Duration of Mechanical Ventilation(upto 2 weeks after surgery)
  • the Duration of Hospital Stay(upto 1 month after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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