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临床试验/NCT03024229
NCT03024229已完成不适用

The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation

University Hospital, Tours4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
IGF

研究概览

简要总结

When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

详细描述

The quality of the renal transplant prior to transplantation is essential for the recovery of graft function in the days following transplantation and its long-term survival. When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Donors aged 18 years or more in brain death or who died of cardiac arrest collected locally in Tours, associated with the major local recipients of the grafts over the same period.

排除标准

  • Kidney transplant removed but stored in a static preservative.
  • Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort® perfusion machine.

结局指标

主要结局

IGF

时间窗: 7 days

Immediate Graft Function (IGF), defined by serum creatinine less than 250 μM / L at day 7 post-kidney transplant, without requiring dialysis of the recipient patient.

次要结局

  • DGF(7 days)
  • BANFF-1(PRE-OPERATIONAL)
  • BANFF-2(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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