A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
研究概览
简要总结
The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.
详细描述
It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years of age
- •Baseline serum creatinine or
- •Calculated creatinine
- •Stable Renal Function
- •Left Ventricular ejection fraction
- •Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required
- •Able to sign informed consent
排除标准
- •Acute renal failure
- •History of Kidney transplant
- •Currently receiving N-acetylcysteine
- •_ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate
- •Left ventricular ejection fraction
- •Pregnant, lactating females
- •Allergy to contrast dye
研究组 & 干预措施
N-Acetylcysteine
Oral N-Acetylcysteine 600 mg
干预措施: Oral N-Acetylcysteine (Drug)
Sodium Bicarbonate
Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
干预措施: Sodium Bicarbonate (Drug)
结局指标
主要结局
Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
时间窗: 2 years
Compare oral N-Acetylcysteine and intravenous sodium bicarbonate for the prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization.
次要结局
未报告次要终点