N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The mean peak increase of serum creatinine concentration during day1 and day2.
研究概览
简要总结
The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant.
详细描述
N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in 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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable Angina pectoris patients
- •Patients who required the coronary catheterization
- •Creatinine clearance rates =<60 mL/min using the Cockcroft-Gault formula
- •Age of 19 or over 19
排除标准
- •Pregnancy
- •Lactation
- •Having received contrast media within 7 days of study entry
- •Emergent coronary angiography
- •Acute renal failure
- •End-stage renal disease requiring dialysis
- •History of hypersensitivity reaction to contrast media
- •Cardiogenic shock
- •Pulmonary edema
- •Multiple myeloma
- •Mechanical ventilation
- •Parenteral use of diuretics
- •Recent use of N-acetylcysteine
- •Recent use of Ascorbic acid
- •Recent use of statin
- •Use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
结局指标
主要结局
The mean peak increase of serum creatinine concentration during day1 and day2.
次要结局
- Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
- from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
- Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
- proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;