A Clinical Pilot Study Investigating the Real-time Dynamics of Glucose, Lactate and Creatinine Concentrations in Marginal Donor Kidneys Undergoing Hypothermic Machine Perfusion
试验速览
- 阶段
- 不适用
- 发起方
- Accunea Ltd.
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Post-operative recovery of kidney function
研究概览
简要总结
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants.
The researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. The researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use.
This pilot study will look at 10 kidneys obtained from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid.
In this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. The researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted.
Combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •All organs to be used in the study must be intended for transplantation and not already rejected/discarded.
- •All organs must be sourced from deceased donors through NHSBT in the normal course of clinical activity.
- •Kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. This typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension.
排除标准
- •Organs from living donors are excluded.
- •Organs from young healthy donors are excluded.
- •Organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. This indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).
结局指标
主要结局
Post-operative recovery of kidney function
时间窗: 30 days post-operatively
Magnitude of change in patient baseline serum creatinine concentration pre- and post-operatively at 30 days (in umol/L)
次要结局
- Reintervention rate(30 days post-operatively)
- Delayed graft function(30 days post-operatively)
- Primary non-function(30 days post-operatively)
- Acute rejection(30 days post-operatively)
- Post-operative complications(30 days post-operatively)