Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
研究概览
简要总结
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.
详细描述
Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.
Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.
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 (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
- •primary deceased renal transplant recipients
- •adult (>18 yo)
排除标准
- •unable to drink N-acetylcysteine during the first 7 PO
- •participation in other study
研究组 & 干预措施
N-acetylcysteine
N-acetylcysteine 600 mg bid po 0-7 PO
干预措施: N-acetylcysteine (Drug)
control
No treatment: standard care provided. No N-acetylcysteine administration.
干预措施: control (Drug)
结局指标
主要结局
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
时间窗: 7 days
次要结局
- Graft function: measure of serum creatinine(3 months)
- Graft function:estimated creatinine clearance by Cokcroft-Gault formula(3 months)
- Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant(3 months)