Hypothermic Oxygenated Perfusion in Extended Criteria Donor Kidney Transplantation—A Randomized Clinical Trial

IF 1.9 4区医学 Q2 SURGERY

Clinical Transplantation Pub Date : 2025-04-28 DOI:10.1111/ctr.70166

Gerti Dajti, Maria Chiara Vaccaro, Giuliana Germinario, Giorgia Comai, Francesca Caputo, Federica Odaldi, Federica Maritati, Lorenzo Maroni, Vania Cuna, Chiara Zanfi, Francesca Rizzo, Enrico Prosperi, Chiara Bonatti, Guido Fallani, Giorgia Radi, Alberto Stocco, Michele Provenzano, Irene Capelli, Massimo Del Gaudio, Gaetano La Manna, Matteo Ravaioli

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引用次数: 0

Abstract

Background

The role of machine perfusion after kidney transplantation (KT) in extended criteria donors (ECD) is unclear, and the current evidence in the literature remains controversial.

Methods

We present an open-label single center randomized trial where 109 patients undergoing KT with ECD grafts between January 2019 and December 2022 were randomized to receive kidneys treated with either hypothermic oxygenated perfusion (HOPE, n = 54) or static cold storage (SCS, n = 55) alone. The primary endpoint was the incidence of delayed graft function (DGF). The secondary endpoints included postoperative complications and graft function and survival in the first year after KT.

Results

The trial failed to meet its primary endpoint. DGF developed in 31 (57%) and 37 (67%) patients in the HOPE and SCS groups, respectively (p = 0.3). Posthoc analysis showed that HOPE was associated with a lower risk for DGF for grafts from donors aged 60 years or older (OR 0.32, 95% CI 0.12–0.87, p = 0.026) and in patients undergoing dual KTs (OR 0.22, 95% CI 0.06–0.87, p = 0.031).

Conclusions

HOPE does not reduce the rate of DGF after KT in ECD donors. However, HOPE appears to be associated with better outcomes in the case of older donors and dual KTs.

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低温氧灌注在扩展标准供肾移植中的应用——一项随机临床试验

肾移植（KT）后机器灌注在扩展标准供体（ECD）中的作用尚不清楚，目前文献中的证据仍存在争议。方法：我们进行了一项开放标签单中心随机试验，在2019年1月至2022年12月期间，109例接受ECD移植的KT患者随机接受低温氧灌注（HOPE, n = 54）或静态冷藏（SCS, n = 55）单独治疗的肾脏。主要终点是移植物功能延迟（DGF）的发生率。次要终点包括术后并发症、移植物功能和KT后第一年的生存率。该试验未能达到其主要终点。HOPE组和SCS组分别有31例（57%）和37例（67%）患者发生DGF （p = 0.3）。事后分析显示，60岁及以上供者的移植物发生DGF的风险较低（or 0.32, 95% CI 0.12-0.87, p = 0.026），而接受双重KTs的患者发生DGF的风险较低（or 0.22, 95% CI 0.06-0.87, p = 0.031）。结论HOPE不能降低ECD供者KT后DGF的发生率。然而，在老年供体和双重KTs的情况下，HOPE似乎与更好的结果有关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Transplantation 医学-外科

CiteScore

3.70

自引率

4.80%

发文量

286

审稿时长

2 months

期刊介绍： Clinical Transplantation: The Journal of Clinical and Translational Research aims to serve as a channel of rapid communication for all those involved in the care of patients who require, or have had, organ or tissue transplants, including: kidney, intestine, liver, pancreas, islets, heart, heart valves, lung, bone marrow, cornea, skin, bone, and cartilage, viable or stored. Published monthly, Clinical Transplantation’s scope is focused on the complete spectrum of present transplant therapies, as well as also those that are experimental or may become possible in future. Topics include: Immunology and immunosuppression; Patient preparation; Social, ethical, and psychological issues; Complications, short- and long-term results; Artificial organs; Donation and preservation of organ and tissue; Translational studies; Advances in tissue typing; Updates on transplant pathology;. Clinical and translational studies are particularly welcome, as well as focused reviews. Full-length papers and short communications are invited. Clinical reviews are encouraged, as well as seminal papers in basic science which might lead to immediate clinical application. Prominence is regularly given to the results of cooperative surveys conducted by the organ and tissue transplant registries. Clinical Transplantation: The Journal of Clinical and Translational Research is essential reading for clinicians and researchers in the diverse field of transplantation: surgeons; clinical immunologists; cryobiologists; hematologists; gastroenterologists; hepatologists; pulmonologists; nephrologists; cardiologists; and endocrinologists. It will also be of interest to sociologists, psychologists, research workers, and to all health professionals whose combined efforts will improve the prognosis of transplant recipients.