Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures
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 CIN in placebo group compared with alpha tocopherol group.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.
详细描述
Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN 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
- Double (Participant, 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
- 否
入选标准
- •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)
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 the contrast agents
- •mechanical ventilation
- •suffered from congestive heart failure, cardiogenic shock or emergent angiography.
- •receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study
研究组 & 干预措施
alpha tocopherol
干预措施: alpha tocopherol (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.
时间窗: 1 year
次要结局
- The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.(1 year)