Oxygenated End-Hypothermic Machine Perfusion in Expanded Criteria Donor Kidney Transplant: A Randomized Clinical Trial
| Autor: | Johann Pratschke, Thomas Minor, Michel Mourad, Vassilios Papalois, Tom Darius, Neal Banga, Laszlo Szabo, Simon R. Knight, Christina Krikke, Catherine Boffa, Maria Irene Bellini, Zoltan Mathe, Rutger J. Ploeg, Lucy Davies, Andreas Paul, Jacques Pirenne, Isabel Quiroga, Laura Mazilescu, Elijah Ablorsu, Ina Jochmans, Dániel Wettstein, Aukje Brat, Orsolya Cseprekál, Peri Husen, Henri G. D. Leuvenink |
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| Přispěvatelé: | Groningen Institute for Organ Transplantation (GIOT), UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service de chirurgie et transplantation abdominale |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
machine perfuison Medizin ischemic-reperfusion injury Cold storage Renal function 030230 surgery Expanded Criteria Donor law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Multicenter trial Clinical endpoint medicine Original Investigation Machine perfusion Intention-to-treat analysis business.industry 3. Good health Surgery 030220 oncology & carcinogenesis business |
| Zdroj: | JAMA Surg JAMA Surgery, 156(6), 517-525. AMER MEDICAL ASSOC JAMA surgery, Vol. 156, no. 6, p. 517-525 (2021) |
| ISSN: | 2168-6254 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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