跳至主要内容
临床试验/NCT06907758
NCT06907758招募中不适用

Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Ratio of creatinine decrease

研究概览

简要总结

Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity.

Graft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors.

Through this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. For simplicity, the investigators will focus on kidney grafts. The aim is to improve the effectiveness of the transplant and reduce waiting times.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • •The inclusion criteria for organ donor patients are as follows:
  • •Adult patient
  • •Brain dead
  • •Hospitalized in surgical intensive care at Strasbourg University Hospital (NHC cardiovascular intensive care unit, NHC multi-purpose intensive care unit, Hautepierre surgical intensive care unit) from January 1, 2018 to December 31, 2023
  • •Having undergone multi-organ transplantation
  • •At least one of the donor kidneys has been transplanted to a patient at Strasbourg University Hospital
  • •Absence of written objection in the medical file of the subject (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.
  • •The inclusion criteria for kidney transplant recipients are as follows:
  • •Adult patient
  • •Recipient of a kidney transplant from an organ donor who meets the inclusion criteria for donor patients mentioned above
  • •Patient who has undergone surgery and is hospitalized post-operatively at Strasbourg University Hospital
  • •Patient monitored by the Strasbourg University Hospital transplant team
  • •Absence of written objection in the subject's medical file (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.

排除标准

  • •Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes
  • •Brain-dead patient who has not undergone organ retrieval
  • •Brain-dead patient whose kidney has not been allocated to a recipient in Strasbourg
  • •Patient transferred to the Strasbourg University Hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval
  • •Kidney transplant patient with a graft from a living donor
  • •Kidney transplant patient with a graft from a deceased donor who is not brain-dead
  • •Kidney transplant patient with a graft from a deceased donor who is brain-dead and hospitalized in a hospital other than Strasbourg

结局指标

主要结局

Ratio of creatinine decrease

时间窗: Days 1 and 2 in kidney transplant recipients

Ratio of creatinine decrease on days 1 and 2 in kidney transplant recipients (formula: CRR2% = ((Cr1-Cr2)\*100)/Cr1) or the need for dialysis before day 2.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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