Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- The incidence of primary graft dysfunction and primary failure
研究概览
简要总结
Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree of dysfunction will be monitored by the method of LIMON, metabonomics techniques and according to the latest published validation Liver Transplantation (16 943-949 2010), total billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days. Liver dysfunction is considered, the presence of a transaminase value> 2000 IU / L 1-7 postoperative day or BT> 10 mg / dl or INR> 1.6, both only in the 7th postoperative day (Olthoff et al Liver Transplantation 16,943 -949 2010).
详细描述
The reason of this study is to evaluate the efficacy of the use of n-acetylcysteine in liver transplant, by administering it in the perfusion liquid, at the time of extraction of the liver of the donor to improve the damage caused by ischemia / reperfusion. The dose is 400 mg in the portal perfusion liquid.
The study included all considered valid and perfused livers. Patients are randomized to contain no drug or n-acetylcysteine by randomization. Then analyzed using blood tests and in the receiver and daily during the first seven days post-transplant hepatic dysfunction parameters, in order to objectify if liver function improves after administration of the antioxidant (n-acetylcysteine ). Safety assessments were performed with intraoperative monitoring anesthetic depth, postoperative parameters of liver and kidney function and graft pathologic examination after perfusion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All grafts perfused by extraction for liver transplantation.
排除标准
- •< 18 years
- •Allergy to NAC
- •Grafts considered invalid for liver transplantation after perfusion
- •Hepatitis fulminant
- •Retransplantation
- •> 10 hours of cold ischemia
- •Patients with asthma
研究组 & 干预措施
N-acetylcysteine
At portal level, a cannula is inserted with the usual technique of infusion of 3000 ml of preservation fluid to free fall as containing or not scrambling inserted by the NAC scrub nurse then (400 mg of N-acetylcysteine at 10%, 4 ml ).
干预措施: N-acetylcysteine (Drug)
Saline
With usual technique
干预措施: Saline (Drug)
结局指标
主要结局
The incidence of primary graft dysfunction and primary failure
时间窗: One week after treatment
Evaluate the incidence of primary graft dysfunction and primary failure in each group of treatment.
次要结局
- To assess the existence of side effects from the use of n-acetylcysteine on liver preservation solution usual.(One week after treatment)
- Reduction of postoperative renal disfunction(One week after treatment)
- Assess levels of glutathione stores achieved following administration of NAC(During harvesting)
- Histological changes(During harvesting)