Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study
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DOI：
10.2196/14622
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发表时间：
2019-10-01
影响因子：
1.7
通讯作者：
Lurje, Georg
中科院分区：
文献类型：
--
作者：
Meister, Franziska Alexandra;Czigany, Zoltan;Lurje, Georg
背景：肾移植是终末期肾病的唯一根治选择。由于没有足够的器官可供移植，导致器官严重短缺。因此，以前被认为不适合移植的同种异体肾脏已经成为扩展标准供体同种异体移植的重要器官池，现在正在全球范围内进行常规移植。然而，这些扩大标准的供者同种异体移植与显著的移植物相关并发症有关。因此，低温氧气机灌流(HOPE)已成为一种强有力的器官保存新技术，并已在肾移植的临床前试验中得到验证。此外，HOPE已经在一些心脏死亡后捐献肝脏的临床系列肝移植中取得了令人振奋的结果。目的：本试验是一项由研究者发起的前瞻性先导性研究，旨在探讨HOPE对脑死亡后用于肾移植的扩展标准供者移植的影响。方法：共有15例具有明确纳入/排除标准的同种异体肾移植患者在植入前通过肾动脉接受2小时HOPE，并将其与30例病例匹配的患者(1：2匹配)进行比较，后者在常规冷藏后进行肾脏移植。一次(移植后7天内透析)和二次(术后并发症、移植物早期功能、住院和重症监护病房停留时间以及移植物存活6个月)终点将在6个月的随访期内进行分析。缺血再灌注损伤的程度将通过肾移植围手术期采集的肾组织、灌流液和血清样本来评估。结果：这项试验的结果预计将于2020年第一季度公布，并将在国内和国际科学会议上公布，并发表在国际同行评议的医学期刊上。该试验于2017年第三季度获得资助，目前正在进行患者招募。结论：这项前瞻性研究旨在探索HOPE对脑死亡后捐赠的扩展标准供者肾移植的影响。本报告是预想结果阶段。
Background: Kidney transplantation is the only curative treatment option for end-stage renal disease. The unavailability of adequate organs for transplantation has resulted in a substantial organ shortage. As such, kidney donor allografts that would have previously been deemed unsuitable for transplantation have become an essential organ pool of extended criteria donor allografts that are now routinely being transplanted on a global scale. However, these extended criteria donor allografts are associated with significant graft-related complications. As a result, hypothermic oxygenated machine perfusion (HOPE) has emerged as a powerful, novel technique in organ preservation, and it has recently been tested in preclinical trials in kidney transplantation. In addition, HOPE has already provided promising results in a few clinical series of liver transplantations where the liver was donated after cardiac death.Objective: The present trial is an investigator-initiated prospective pilot study on the effects of HOPE on extended criteria donor allografts donated after brain death and used in kidney transplantation.Methods: A total of 15 kidney allografts with defined inclusion/exclusion criteria will be submitted to two hours of HOPE via the renal artery before implantation, and are going to be compared to a case-matched group of 30 patients (1:2 matching) who had kidneys transplanted after conventional cold storage. Primary (posttransplant dialysis within 7 days) and secondary (postoperative complications, early graft function, duration of hospital and intensive care unit stay, and six-month graft survival) endpoints will be analyzed within a six-month follow-up period. The extent of ischemia-reperfusion injury will be assessed using kidney tissue, perfusate, and serum samples taken during the perioperative phase of kidney transplantationResults: The results of this trial are expected in the first quarter of 2020 and will be presented at national and international scientific meetings and published in international peer-reviewed medical journals. The trial was funded in the third quarter of 2017 and patient enrollment is currently ongoing.Conclusions: This prospective study is designed to explore the effects of HOPE on extended criteria donor kidney allografts donated after brain death. The present report represents the preresults phase.