N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of CIN
研究概览
简要总结
In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC.
This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com).
Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •18 years of age or older.
- •Hospitalized with a primary diagnosis of acute coronary syndrome.
- •Scheduled for coronary angiography or intervention during the current hospitalization.
排除标准
- •Have end-stage renal disease (ESRD) requiring dialysis.
- •Have a known hypersensitivity to NAC.
- •Have a history of life-threatening contrast reaction. -
研究组 & 干预措施
intravenous N-acetlycysteine
intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)as compared to placebo
Acetadote provided by Cumberland Pharmaceuticals Inc.
干预措施: intravenous NAC (Drug)
Placebo
Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of CIN
时间窗: 48-72 hours
次要结局
- in-hospital mortality(30 days)
- 30 day mortality(30 days)
- duration of hospitalization(30 days)
- serum cystatin C(48-72 hours)