Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Graft survival
研究概览
简要总结
Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).
详细描述
Anti-oxidant agents have the potential to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT). In this randomized prospective study, we seek to study the impact on the post-LT outcome of the infusion of N-acetylcysteine (NAC) during the liver procurement procedure.
Potential grafts, assigned to adult candidates with chronic liver disease enlisted for first LT, will randomly be included in a one-to-one ratio with a sequential closed envelope single-blinded assignation procedure to either the NAC protocol or in the standard procedure (without NAC).
The NAC protocol comprises: a systemic NAC infusion (30 mg/kg) one hour before the beginning of liver procurement; a loco-regional NAC infusion (300 mg through the portal vein) just before cross-clamping.
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
- Single (Participant)
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
- •all consecutive subjects with chronic liver disease undergoing first Liver Transplantation receiving deceased donor livers
排除标准
- •recipients with acute liver disease;
- •paediatric patients or adult patients receiving a liver from a paediatric donor;
- •patients undergoing multiple-organ transplantation;
- •patients undergoing re-transplantation of the Liver;
- •patients undergoing living donor Liver Transplantation
研究组 & 干预措施
NAC procurement protocol
The allocated organ, in addition to the standard procedure, was treated with a systemic NAC infusion before initiating the liver harvesting procedure, and a loco-regional infusion into the portal vein before cross-clamping.
干预措施: N-acetylcystein (Drug)
结局指标
主要结局
Graft survival
时间窗: up to 60 months
次要结局
- Patient survival(up to 60 months)
- Primary graft dysfunction(up to 60 months)
研究者
Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Azienda Ospedaliera di Padova