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Randomized Controlled Trial
. 2021 Jun 1;156(6):517-525.
doi: 10.1001/jamasurg.2021.0949.

Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant: A Randomized Clinical Trial

Peri Husen  1 , Catherine Boffa  2 , Ina Jochmans  3   4 , Christina Krikke  5 , Lucy Davies  2 , Laura Mazilescu  1 , Aukje Brat  5 , Simon Knight  2 , Daniel Wettstein  6 , Orsolya Cseprekal  6   7 , Neal Banga  8 , Maria Irene Bellini  9 , Laszlo Szabo  10 , Elijah Ablorsu  10 , Tom Darius  11 , Isabel Quiroga  12 , Michel Mourad  11 , Johann Pratschke  13 , Vassilios Papalois  14 , Zoltan Mathe  6   15 , Henri G D Leuvenink  5 , Thomas Minor  1 , Jacques Pirenne  3   4 , Rutger J Ploeg  2 , Andreas Paul  1
Affiliations
Randomized Controlled Trial

Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant: A Randomized Clinical Trial

Peri Husen et al. JAMA Surg. .

Abstract

Importance: 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).

Objective: 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.

Design, setting, and participants: 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.

Interventions: On randomization and before implantation, deceased donor kidneys were either kept on SCS or placed on HMPo2.

Main outcome and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: isrctn.org Identifier: ISRCTN63852508.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Husen reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Boffa reports other support from Astellas Pharma outside the submitted work. Dr Jochmans reports grants from European Union 7th Framework Programme during the conduct of the study and other support from European Society for Organ Transplantation and European Association for the Study of the Liver outside the submitted work. Dr Knight reports personal fees from OrganOx for clinical trial design outside the submitted work. Dr Leuvenink reports grants from European Union 7th Framework Programme during the conduct of the study. Dr Minor reports grants from the European Union during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Enrollment of Kidneys in the Trial
end-HMPo2, hypothermic machine perfusion preservation; ITT, intention-to-treat; SCS, static cold storage.
Figure 2.
Figure 2.. Kaplan-Meier Curve for Death-Censored Graft Survival
end-HMPo2, hypothermic machine perfusion preservation; HR, hazard ratio; SCS, static cold storage.
See this image and copyright information in PMC

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