Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Incidence of Contrast Induced Nephropathy(CIN)
研究概览
简要总结
This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.
The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.
详细描述
Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).
The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Diabetic patients.
- •eGFR < 60 ml/min/1.73m
- •Scheduled for primary or elective PCI.
排除标准
- •Non diabetic patients.
- •Patients with eGFR ≥ 60 ml/min/1.73m
- •Chronic renal replacement therapy.
- •Subject with active malignancy.
- •Subject with any known history of seizure disorders.
- •Subject with polycythemia.
- •Uncontrolled hypertension.
- •Known allergy or hypersensitivity to EPO.
- •Use of EPO 1 week prior to randomization.
- •Use of long acting EPO (CERA) during 1 month prior to randomization.
- •Use of NAC or bicarbonate during 3 days prior to randomization.
- •Contrast media exposure during the last 7 days before randomization.
- •Pregnant or lactating women.
- •Participation in other clinical trial.
- •Refusal or inability to give informed consent due to mental or physical state.
研究组 & 干预措施
Erythropoietin
干预措施: Epoetin beta (Drug)
Placebo
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Incidence of Contrast Induced Nephropathy(CIN)
时间窗: 1-3 days after exposure to contrast media
次要结局
- Hospital mortality(participants will be followed after PCI procedure till discharge, an expected average of 1-2 days)
- Enzymatic infarct size(6h and 12 h after exposure to contrast media)
- Renal replacement therapy(participants will be followed after PCI procedure till discharge, an expected average of 1-2 days)
- Hospital length of stay(participants will be followed for the duration of hospital stay, an expected average of 3 days)