Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
研究概览
简要总结
Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant
详细描述
- To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
- To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
- To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First liver transplant
- •Normal renal function before transplantation [serum creatinine ≤ 1.5 mg / dl]
- •No requirements for dialysis before transplantation
- •Age greater than 18 years
排除标准
- •Re-transplant
- •Renal dysfunction i.e. serum creatinine > 1.5 mg/dl
- •Need for dialysis before transplantation
- •Presence of Hepatorenal or Hepatopulmonary syndrome*
- •Combined liver and kidney transplant
- •Peptic ulcer disease
- •Pregnancy
研究组 & 干预措施
600 mg N-acetylcysteine or placebo IV
600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,
干预措施: N-acetylcysteine (Drug)
600 mg N-acetylcysteine or placebo IV
600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,
干预措施: Placebo (Drug)
600 mg N-acetylcysteine or placebo NG
600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,
干预措施: N-acetylcysteine (Drug)
600 mg N-acetylcysteine or placebo NG
600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,
干预措施: Placebo (Drug)
N-acetylcysteine or placebo q 12 hour
600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period.
干预措施: N-acetylcysteine (Drug)
N-acetylcysteine or placebo q 12 hour
600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period.
干预措施: Placebo (Drug)
结局指标
主要结局
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
时间窗: 6 months
Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.
次要结局
- iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation(6 months)
- To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection(6 months)