Efficacy Of Statins In The Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Insufficiency (SCIN Trial): A Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
研究概览
简要总结
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
详细描述
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults > 18 years of age
- •undergoing coronary or peripheral angiography with or without intervention
- •Cr > 1.3 mg/dL or GFR < 60 mL/min
排除标准
- •end-stage renal disease on dialysis
- •acute renal failure
- •previous iodinated contrast media exposure within 7 days of study entry
- •history of hypersensitivity to statins
- •pregnancy or lactation
- •emergent coronary angiography, ST elevation myocardial infarction (STEMI), or cardiogenic shock
- •prisoners
- •patients already on maximum dose of statins
- •patient receiving N-acetylcysteine or sodium bicarbonate
研究组 & 干预措施
atorvastatin
干预措施: atorvastatin (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.
时间窗: 48 hours
Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of \> 0.5 mg/dL or \>25% Increase From Baseline at 24 \& at 48 Hours
次要结局
未报告次要终点