边缘供肾肾移植中低温氧合灌注的随机临床试验

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

作者信息

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

机构信息

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

出版信息

Clin Transplant. 2025 May;39(5):e70166. doi: 10.1111/ctr.70166.

DOI:10.1111/ctr.70166

PMID:40294124

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12036954/

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.

摘要

背景

肾移植（KT）后机器灌注在扩大标准供体（ECD）中的作用尚不清楚，目前文献中的证据仍存在争议。

方法

我们开展了一项开放标签的单中心随机试验，2019年1月至2022年12月期间，109例接受ECD肾移植的患者被随机分组，分别接受低温氧合灌注（HOPE，n = 54）或单纯静态冷藏（SCS，n = 55）处理的肾脏。主要终点是移植肾功能延迟恢复（DGF）的发生率。次要终点包括术后并发症、移植肾功能以及肾移植后第一年的生存率。

结果

该试验未达到其主要终点。HOPE组和SCS组分别有31例（57%）和37例（67%）患者发生DGF（p = 0.3）。事后分析表明，对于60岁及以上供体的移植物以及接受双侧肾移植的患者，HOPE与较低的DGF风险相关（OR 0.32，95% CI 0.12 - 0.87，p = 0.026）（OR 0.22，95% CI 0.06 - 0.87，p = 0.031）。