N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
研究概览
简要总结
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.
详细描述
BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.
METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.
Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who will received cardiac surgery with cardiopulmonary bypass
排除标准
- •Dialyzed patients
- •Acute renal failure
- •Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
- •Acute chronic obstructive lung disease or asthma exacerbation
- •Allergy to N-acetylcysteine
结局指标
主要结局
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
次要结局
未报告次要终点