Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary end-point of this study is the development of AKI in placebo group compared with EPO group.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.
详细描述
Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years.
- •serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
- •patients who need cardiac surgery
排除标准
- •patients with acute kidney injury
- •end stage renal disease (requiring dialysis)
- •unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study)
- •allergy to any of erythropoietin
- •suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.
- •receiving erythropoietin within 14 days before the study
研究组 & 干预措施
placebo
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
干预措施: placebo (Drug)
Erythropoietin
The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.
干预措施: beta erythropoietin (Drug)
结局指标
主要结局
The primary end-point of this study is the development of AKI in placebo group compared with EPO group.
时间窗: 1.5 year
次要结局
- The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups(1.5 year)