Oxygenated end-hypothermic machine perfusion in expanded criteria donor kidney transplant: a randomized clinical trial

<p><strong>Importance</strong> Continuous hypothermic machine perfusion during organ preservation has a beneficial effect on graft function and survival in kidney transplant when compared with static cold storage (SCS).</p> <p><strong>Objective</strong> T...

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Détails bibliographiques
Auteurs principaux: Husen, P, Boffa, C, Jochmans, I, Krikke, C, Davies, L, Mazilescu, L, Brat, A, Knight, SR, Wettstein, D, Cseprekal, O, Banga, N, Bellini, MI, Szabo, L, Ablorsu, E, Darius, T, Quiroga, I, Mourad, M, Pratschke, J, Papalois, V, Mathe, Z, Leuvenink, HGD, Minor, T, Pirenne, J, Ploeg, RJ, Paul, A
Format: Journal article
Langue:English
Publié: American Medical Association 2021
Description
Résumé:<p><strong>Importance</strong> Continuous hypothermic machine perfusion during organ preservation has a beneficial effect on graft function and survival in kidney transplant when compared with static cold storage (SCS).</p> <p><strong>Objective</strong> To compare the effect of short-term oxygenated hypothermic machine perfusion preservation (end-HMPo2) after SCS vs SCS alone on 1-year graft survival in expanded criteria donor kidneys from donors who are brain dead.</p> <p><strong>Design, Setting, and Participants</strong> In a prospective, randomized, multicenter trial, kidneys from expanded criteria donors were randomized to either SCS alone or SCS followed by end-HMPo2 prior to implantation with a minimum machine perfusion time of 120 minutes. Kidneys were randomized between January 2015 and May 2018, and analysis began May 2019. Analysis was intention to treat.</p> <p><strong>Interventions</strong> On randomization and before implantation, deceased donor kidneys were either kept on SCS or placed on HMPo2.</p> <p><strong>Main Outcome and Measures</strong> Primary end point was 1-year graft survival, with delayed graft function, primary nonfunction, acute rejection, estimated glomerular filtration rate, and patient survival as secondary end points.</p> <p><strong>Results</strong> Centers in 5 European countries randomized 305 kidneys (median [range] donor age, 64 [50-84] years), of which 262 kidneys (127 [48.5%] in the end-HMPo2 group vs 135 [51.5%] in the SCS group) were successfully transplanted. Median (range) cold ischemia time was 13.2 (5.1-28.7) hours in the end-HMPo2 group and 12.9 (4-29.2) hours in the SCS group; median (range) duration in the end-HMPo2 group was 4.7 (0.8-17.1) hours. One-year graft survival was 92.1% (n = 117) in the end-HMPo2 group vs 93.3% (n = 126) in the SCS group (95% CI, −7.5 to 5.1; P = .71). The secondary end point analysis showed no significant between-group differences for delayed graft function, primary nonfunction, estimated glomerular filtration rate, and acute rejection.</p> <p><strong>Conclusions and Relevance</strong> Reconditioning of expanded criteria donor kidneys from donors who are brain dead using end-HMPo2 after SCS does not improve graft survival or function compared with SCS alone. This study is underpowered owing to the high overall graft survival rate, limiting interpretation.</p> <p><strong>Trial Registration</strong> isrctn.org Identifier: ISRCTN63852508</p>