肾脏供体中的低温保存或机器灌注

Hypothermia or Machine Perfusion in Kidney Donors.

作者信息

Malinoski Darren, Saunders Christina, Swain Sharon, Groat Tahnee, Wood Patrick R, Reese Jeffrey, Nelson Rachel, Prinz Jennifer, Kishish Kate, Van De Walker Craig, Geraghty P J, Broglio Kristine, Niemann Claus U

机构信息

From the Division of Trauma, Critical Care, and Acute Care Surgery, Oregon Health and Science University (D.M., T.G., R.N.), and the Pacific Northwest Transplant Bank (C.V.D.W.) - both in Portland; Berry Consultants, Austin (C.S., K.B.), LifeGift, Houston (P.R.W.), and South West Transplant Alliance, Dallas (J.R.) - all in Texas; Donor Alliance, Denver (J.P.); LifeSource, Minneapolis (K.K.); Donor Network Arizona, Tempe (P.J.G.); and Donor Network West, San Ramon (S.S.), and the Department of Anesthesia and Perioperative Care and the Department of Surgery, Division of Transplantation (C.U.N.), University of California, San Francisco - both in California.

出版信息

N Engl J Med. 2023 Feb 2;388(5):418-426. doi: 10.1056/NEJMoa2118265.

DOI:10.1056/NEJMoa2118265

PMID:36724328

Abstract

BACKGROUND

Therapeutic hypothermia in brain-dead organ donors has been shown to reduce delayed graft function in kidney recipients after transplantation. Data are needed on the effect of hypothermia as compared with machine perfusion on outcomes after kidney transplantation.

METHODS

At six organ-procurement facilities in the United States, we randomly assigned brain-dead kidney donors to undergo therapeutic hypothermia (hypothermia group), ex situ kidney hypothermic machine perfusion (machine-perfusion group), or both (combination-therapy group). The primary outcome was delayed graft function in the kidney transplant recipients (defined as the initiation of dialysis during the first 7 days after transplantation). We also evaluated whether hypothermia alone was noninferior to machine perfusion alone and whether the combination of both methods was superior to each of the individual therapies. Secondary outcomes included graft survival at 1 year after transplantation.

RESULTS

From 725 enrolled donors, 1349 kidneys were transplanted: 359 kidneys in the hypothermia group, 511 in the machine-perfusion group, and 479 in the combined-therapy group. Delayed graft function occurred in 109 patients (30%) in the hypothermia group, in 99 patients (19%) in the machine-perfusion group, and in 103 patients (22%) in the combination-therapy group. Adjusted risk ratios for delayed graft function were 1.72 (95% confidence interval [CI], 1.35 to 2.17) for hypothermia as compared with machine perfusion, 1.57 (95% CI, 1.26 to 1.96) for hypothermia as compared with combination therapy, and 1.09 (95% CI, 0.85 to 1.40) for combination therapy as compared with machine perfusion. At 1 year, the frequency of graft survival was similar in the three groups. A total of 10 adverse events were reported, including cardiovascular instability in 9 donors and organ loss in 1 donor owing to perfusion malfunction.

CONCLUSIONS

Among brain-dead organ donors, therapeutic hypothermia was inferior to machine perfusion of the kidney in reducing delayed graft function after transplantation. The combination of hypothermia and machine perfusion did not provide additional protection. (Funded by Arnold Ventures; ClinicalTrials.gov number, NCT02525510.).

摘要

背景

脑死亡器官捐献者进行治疗性低温已被证明可减少肾移植受者移植后的移植肾功能延迟恢复。需要有关低温与机器灌注相比对肾移植后结局影响的数据。

方法

在美国的六个器官获取机构，我们将脑死亡肾捐献者随机分配接受治疗性低温（低温组）、离体肾低温机器灌注（机器灌注组）或两者（联合治疗组）。主要结局是肾移植受者的移植肾功能延迟恢复（定义为移植后第1个7天内开始透析）。我们还评估了单纯低温是否不劣于单纯机器灌注，以及两种方法联合是否优于每种单独治疗。次要结局包括移植后1年的移植物存活。

结果

从725名登记的捐献者中，共移植了1349个肾脏：低温组359个肾脏，机器灌注组511个肾脏，联合治疗组479个肾脏。低温组109例患者（30%）发生移植肾功能延迟恢复，机器灌注组99例患者（19%）发生，联合治疗组103例患者（22%）发生。与机器灌注相比，低温导致移植肾功能延迟恢复的校正风险比为1.72（95%置信区间[CI]，1.35至2.17）；与联合治疗相比，低温为1.57（95%CI，1.26至1.96）；与机器灌注相比，联合治疗为1.09（95%CI，0.85至1.40）。1年时，三组的移植物存活频率相似。共报告了10起不良事件，包括9名捐献者出现心血管不稳定和1名捐献者因灌注故障导致器官丢失。