Prevention of Acute Kidney Injury (AKI) by Erythropoietin (EPO) in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had AKI (Acute Kidney Injury)
研究概览
简要总结
The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.
详细描述
Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective CABG over age 18
排除标准
- •Under age 18
- •Emergent CABG
- •Prior exposure to nephrotoxic drug
- •Dialysis patients
- •Uncontrolled hypertension
研究组 & 干预措施
EPO group
干预措施: Erythropoietin-Beta (Drug)
Placebo group
干预措施: Normal Saline (Drug)
结局指标
主要结局
Number of Participants Who Had AKI (Acute Kidney Injury)
时间窗: at any time within the first 5 days after surgery
number of participants who had 50% increase in serum creatinine levels from baseline
次要结局
- Change in Estimated Glomerular Filtration Rate (eGFR)(during the first 5 days after surgery)