A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional delayed graft function
研究概览
简要总结
The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.
详细描述
Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).
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
- 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
- •Listed for a renal transplantation due to end stage renal disease
- •Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.
排除标准
- •Multi-organ recipients
- •Dual kidney transplantation
研究组 & 干预措施
I-HMPO2
intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport)
干预措施: Oxygen (Drug)
C-HMPO2
continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)
干预措施: Oxygen (Drug)
结局指标
主要结局
Functional delayed graft function
时间窗: first 7 days after transplantation
defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)
次要结局
- Patient survival (censored and uncensored for death)(From 1-365 days after transplantation)
- Glomerular filtration rate at 1 year after transplantation(At 1 year after transplantation (window 30 days))
- Primary non-function(Until 3 months after transplantation)
- Metabolic analysis on preservation fluid(Baseline and pre-surgery)
- Need for dialysis after transplantation(0-30 days after transplantation)
- Biopsy-proven acute rejection(Until 1 year after transplantation with window of 10 days)
- Graft survival(From 1-365 days after transplantation)
- Estimated glomerular filtration rate(At 3, 6, and 12 months after transplantation with window of 10 days)
- Delayed graft function(first 7 days after transplantation)
- Serum creatinine reduction ratio(Day 1-2 after transplantation)
- Metabolic analysis on kidney preservation tissue(Baseline and pre-surgery)