Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
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
- 否
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
We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
干预措施: saline (Drug)
erythropoietin group
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)
