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Original Investigation
April 21, 2021

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

Author Affiliations
  • 1Department of General, Visceral and Transplantation Surgery, University Hospital Essen, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
  • 2Nuffield Department of Surgical Sciences, University of Oxford, United Kingdom
  • 3Transplant Research Group, Laboratory of Abdominal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium
  • 4Abdominal Transplant Surgery, University Hospitals Leuven, Leuven, Belgium
  • 5Department of Surgery, University Medical Center Groningen, the Netherlands
  • 6Department of Transplantation and Surgery, Semmelweis University, Budapest, Hungary
  • 7International Nephrology Research and Training Center (INRTC), Budapest, Hungary
  • 8Department of General Surgery, Royal Free Hospital, London, United Kingdom
  • 9Renal Transplant Unit, Belfast City Hospital, Belfast, United Kingdom
  • 10Nephrology and Transplant Directorate, University Hospital of Wales, Cardiff, United Kingdom
  • 11Surgery and Abdominal Transplant Unit, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  • 12Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom
  • 13Department of Surgery, Charité, Berlin, Germany
  • 14Department of Surgery, Imperial College London, London, United Kingdom
  • 15Department of Transplantation and Surgery, Medical University of Vienna, Vienna, Austria
JAMA Surg. Published online April 21, 2021. doi:10.1001/jamasurg.2021.0949
Key Points

Question  Does preimplantation short-term reconditioning of kidney grafts using oxygenated hypothermic machine perfusion for at least 2 hours after an initial period of static cold storage lead to an improvement of 1-year graft survival in kidneys retrieved from expanded criteria donors?

Findings  In this randomized clinical trial of 305 kidneys, 1-year graft survival was equal between kidneys that were machine perfused following static cold storage and kidneys that remained on static cold storage prior to implantation without oxygenated hypothermic machine perfusion.

Meaning  These findings suggest that the use of oxygenated hypothermic machine perfusion prior to implantation and following a period of static cold storage does not improve graft survival or kidney function in kidneys retrieved from donors who are brain dead meeting the expanded donor criteria.

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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