A Prospective, Randomized Trial to Investigate the Effects of Glucose/ Ischemic Preconditioning Donor Pre-treatment on Reperfusion Injury in Deceased-Donor Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reperfusion injury determined by peak AST
研究概览
简要总结
Standard liver retrieval procedures for transplantation from a deceased donor inevitably result in a "reperfusion injury" to the liver tissue. The purpose of this research study is to find out whether treatment of the liver with a "preconditioning" protocol before its removal from the donor will help reduce any of this injury.
The "preconditioning" treatment being tested has two components. Firstly, a solution of glucose+insulin is infused and secondly, blood flow to the liver is stopped briefly (10 minutes) and then resumed. Both strategies, individually, have been shown to reduce liver tissue injury in human studies.
We hypothesize that combining both strategies will have a clinical benefit to patients and will improve liver function following transplant.
详细描述
Liver transplantation is the only chance of cure for patients with end-stage liver disease. Unfortunately, standard organ preservation results in an ischemic-reperfusion injury (IRI) at the time of graft implantation. Novel strategies have been proposed to decrease reperfusion injury and improve graft function. This study will be the first to combine both strategies in a randomized, prospective trial. The intervention will occur during the retrieval surgery prior to cold preservation. Briefly, a glucose and insulin solution will be infused via the mesenteric vein at a controlled rate. Immediately prior to cross-clamping, blood supply to the liver will be restricted for 10 minutes and then resumed for 10 minutes before beginning cold preservation. All remaining surgical procedures, including the recipient surgery, will be performed by standard techniques. The liver recipient does not directly receive any intervention during this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient 18 years of age or older
- •Recipient with chronic end-stage liver disease
- •Deceased donor liver transplant
- •Recipient capable of providing written informed consent
- •Whole organ graft from donors aged 60 years or older
排除标准
- •Fulminant liver failure
- •Objection by any other member of the retrieval team
- •Split-liver grafts
- •Donor that has received total parenteral nutrition within 24hr of organ retrieval Donors from whom the pancreas and/or small bowel are also being retrieved
结局指标
主要结局
Reperfusion injury determined by peak AST
时间窗: first 24 hours post-operative
次要结局
- Biliary Complications, infection and rejection(first month post-transplantation)
- Liver ATP and glycogen content; blood cytokine levels; liver gene expression of pro- and anti-apoptotic genes(immediately pre-removal and post- transplantation)
- graft and patient survival; length of hospital stay; length of ICU stay(30 days and 90 days post-transplantation)