A Single Centre Study of the Feasibility and Safety of Using Normothermic ex Vivo Machine Perfusion to Store Human Kidneys for Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The rate of kidney discard or graft failure attributable to the study intervention
研究概览
简要总结
Kidney transplantation is the treatment of choice for end-stage kidney failure, but access to transplantation is limited by a severe shortage of donor organs. Although the use of kidneys from higher risk deceased donors has increased the availability of organs, these grafts are associated with a greater risk of delayed function, inferior performance, and shorter survival than standard criteria donor kidneys. The current standard of care for kidney graft preservation prior to transplantation is static cold storage. Preliminary results from large animal kidney transplantation studies and a human clinical trial suggest that normothermic machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by kidney grafts during cold static preservation, allow assessment of organ viability prior to transplantation, and reduce the risk of delayed graft function or non-function. Such a strategy may not only improve the performance of kidneys that are currently considered acceptable for transplantation, but may also facilitate the assessment and utilization of kidneys that are currently not considered for transplantation. This study will examine the feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to transplantation. The study will evaluate kidney function after transplantation using standard clinical parameters. Study participants will be followed for 3 months following transplantation and their outcomes recorded. Feasibility will be measured using the ratio of actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take into account logistical issues with respect to implementation and ease of use of the ex vivo perfusion device. Safety will be assessed by rates of device failure resulting in organ discard, primary graft non-function, delayed graft function, graft failure, and recipient mortality.
详细描述
Kidney transplantation is the treatment of choice for suitable patients with end-stage renal disease as it results in lower morbidity and mortality rates when compared to dialysis. Unfortunately, the number of patients referred for transplantation has grown more quickly than the number of suitable grafts from deceased donors.
The use of higher risk organs has expanded the donor pool but at a great cost due to the higher probability that higher risk kidneys will never function (primary non-function, PNF), or will have delayed graft function (DGF). The current standard of care for kidney graft preservation prior to transplantation is static cold storage but higher-risk deceased donor kidneys are particularly vulnerable to the effects of cold storage. Preliminary results from large animal kidney transplantation studies and a human clinical trial suggest that normothermic machine perfusion of kidneys prior to transplantation may ameliorate the injury sustained by kidney grafts during cold static preservation, allow assessment of organ viability prior to transplantation, and reduce the risk of delayed graft function or non-function. Such a strategy may not only improve the performance of kidneys that are currently considered acceptable for transplantation, but may also facilitate the assessment and utilization of kidneys that are currently not considered for transplantation.
This study will examine the feasibility and safety of normothermic ex vivo perfusion of human kidneys prior to transplantation. Kidneys will be retrieved in the standard fashion and stored cold during transit. Upon arrival at the study transplant centre, kidneys will begin perfusion with a normothermic near-physiologic, blood-based solution. Perfusion will last 1-10 hours.
The study will evaluate kidney function after transplantation using standard clinical parameters. Study participants (n=25) will be followed for 3 months following transplantation and their outcomes recorded. Feasibility will be measured using the ratio of actual:eligible kidney grafts preserved by normothermic ex vivo perfusion and will also take into account logistical issues with respect to implementation and ease of use of the ex vivo perfusion device. Safety will be assessed by rates of device failure resulting in organ discard, primary graft non-function, delayed graft function, graft failure, and recipient mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Normothermic perfusion
Kidneys retrieved from deceased donors will undergo the study intervention consisting of 4-10 hours of Normothermic ex-vivo perfusion using a blood-based solution, prior to implantation in the transplant recipient
干预措施: Normothermic ex-vivo kidney perfusion Solution -Toronto (Drug)
结局指标
主要结局
The rate of kidney discard or graft failure attributable to the study intervention
时间窗: from date of first actual intervention to date last participant completes the study followup period of 3 months post-intervention
organ discard or graft failure directly attributable to the use of normothermic perfusion
the ratio of actual / eligible kidney grafts subjected to study intervention.
时间窗: assessed 3 months after enrollment of final participant, or up to 48 months, whichever is earlier
planned versus actual kidney perfusions to assess study feasibility
次要结局
- duration of post-transplant dialysis(3 months post-kidney transplantation)
- rate of primary graft non-function compared to historical, case-matched controls(3 months post-kidney transplantation)
- Degree of Ischemia-reperfusion injury as assessed by post-reperfusion kidney biopsies(assessed 3 months after enrollment of final participant)
- Rate of delayed graft function(3 months post-kidney transplantation)