EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in plasma cystatin C measured on day 3 postoperatively.
研究概览
简要总结
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.
详细描述
Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.
Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.
Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •The patient is scheduled for non-emergent CABG surgery.
- •CyC eGFR or MDRD eGFR < 60 ml/min.
- •The patient has given his/her written consent to participate
排除标准
- •The patient has an uncontrolled hypertension.
- •Hypersensitivity to the active drug.
- •The patient is pregnant or is a fertile woman (<50 years).
- •The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
- •Preoperative CyC eGFR or MDRD eGFR is < 15, or the patient is treated with dialysis.
- •The patient has a known malignancy.
- •The patient is planned for Off-pump CABG surgery.
- •The patient is included in other ongoing clinical trial. Yes / No
- •Clinically judgment by the investigator that the patient should not participate in the study.
研究组 & 干预措施
Placebo
Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.
干预措施: Placebo (Drug)
Erythropoietin
• Active substance: Erythropoietin zeta with the ATC-code: B03XA01. The drug is a Clear colorless solution for injection. The active substance will be diluted with NaCl 9mg/ml to a to a concentration of 2000 U/ml. A dose of 400U/kg will be prepared and marked before the operation. The drug will be administrated after the anesthesia induction and before the start of surgery.
干预措施: Erythropoietin zeta (Drug)
结局指标
主要结局
Change in plasma cystatin C measured on day 3 postoperatively.
时间窗: 3 days postoperatively
次要结局
未报告次要终点