目标低温治疗对扩大标准器官捐献者受者肾脏移植物功能的影响：多中心随机对照试验（HYPOREME）研究方案。
Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME).
机构信息
Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire de Nantes, Nantes, France
出版信息
BMJ Open. 2022 Mar 28;12(3):e052845. doi: 10.1136/bmjopen-2021-052845.
INTRODUCTION
Expanded-criteria donors (ECDs) are used to reduce the shortage of kidneys for transplantation. However, kidneys from ECDs are associated with an increased risk of delayed graft function (DGF), a risk factor for allograft loss and mortality. HYPOREME will be a multicentre randomised controlled trial (RCT) comparing targeted hypothermia to normothermia in ECDs, in a country where the use of machine perfusion for organ storage is the standard of care. We hypothesise that hypothermia will decrease the incidence of DGF.
METHODS AND ANALYSIS
HYPOREME is a multicentre RCT comparing the effect on kidney function in recipients of targeted hypothermia (34°C-35°C) and normothermia (36.5°C-37.5°C) in the ECDs. The temperature intervention starts from randomisation and is maintained until aortic clamping in the operating room. We aim to enrol 289 ECDs in order to analyse the kidney function of 516 recipients in the 53 participating centres. The primary outcome is the occurrence of DGF in kidney recipients, defined as a requirement for renal replacement therapy within 7 days after transplantation (not counting a single session for hyperkalemia during the first 24 hours). Secondary outcomes include the proportion of patients with individual organs transplanted in each group; the number of organs transplanted from each ECD and the vital status and kidney function of the recipients 7 days, 28 days, 3 months and 1 year after transplantation. An interim analysis is planned after the enrolment of 258 kidney recipients.
ETHICS AND DISSEMINATION
The trial was approved by the ethics committee of the French Intensive Care Society (CE-SRLF-16-07) on 26 April 2016 and by the competent French authorities on 20 April 2016 (Comité de Protection des Personnes-TOURS-Région Centre-Ouest 1, registration #2016-S3). Findings will be published in peer-reviewed journals and presented during national and international scientific meetings.
TRIAL REGISTRATION NUMBER
NCT03098706.
介绍
扩大标准供者（ECD）用于减少移植用肾脏的短缺。然而，ECD 来源的肾脏与延迟移植物功能障碍（DGF）风险增加相关，DGF 是同种异体移植物丢失和死亡的一个危险因素。HYPOREME 将是一项多中心随机对照试验（RCT），比较 ECD 中目标低温与常规体温的效果，在这个国家，器官保存使用机器灌注是标准的护理方法。我们假设低温会降低 DGF 的发生率。
方法和分析
HYPOREME 是一项多中心 RCT，比较 ECD 中目标低温（34°C-35°C）和常规体温（36.5°C-37.5°C）对受体肾功能的影响。温度干预从随机分组开始，并持续到手术室中的主动脉夹闭。我们旨在招募 289 名 ECD，以便在 53 个参与中心的 516 名受体中分析肾功能。主要结局是肾移植受体发生 DGF，定义为移植后 7 天内需要肾脏替代治疗（不包括前 24 小时内单次高钾血症）。次要结局包括每组中移植的个体器官比例；每组 ECD 移植的器官数量以及受体移植后 7 天、28 天、3 个月和 1 年的存活状态和肾功能。计划在招募 258 名肾移植受体后进行中期分析。
伦理和传播
该试验于 2016 年 4 月 26 日获得法国重症监护学会伦理委员会（CE-SRLF-16-07）的批准，并于 2016 年 4 月 20 日获得法国主管当局的批准（Comité de Protection des Personnes-TOURS-Région Centre-Ouest 1，注册号#2016-S3）。研究结果将发表在同行评议的期刊上，并在国家和国际科学会议上展示。
试验注册号
NCT03098706。
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