Oxygenated Hypothermic Machine Perfusion Of Kidneys Donated After Circulatory Death: An International Randomised Controlled Trial
(2019) 26th BTS Annual Congress 2019 — Location: Antwerp, Belgium (14.March.2019)
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- METHODS : An international, double-blinded, randomised, paired trial investigated the effect of oxygenated (HMPO) vs non-oxygenated hypothermic machine perfusion (HMP) on 1y graft function in cDCD kidneys 50 years of age or older. Kidneys were pumped from retrieval until transplantation. Primary endpoint was eGFR at 1y post-transplant (CKD-EPI) (90% power, alpha=0.05 to detect 8ml/min/1.73m² difference). A pre-specified sensitivity analysis accounted for cases where no 1yeGFR was available due to graft loss (eGFR imputed as 10 mL/min/1.73m²) or patient death with functioning graft (last known eGFR carried forward). RESULTS : 197 kidney pairs (median donor age 56y (range: 50-78)), of which 106 pairs were successfully transplanted (recipient age 61y (21-79)). Total donor warm ischemia time was 28.5min (8-114). Cold and pump times were 11h (4.6-27.6), 6.9h (1.7-24.3) in HMPO and 10.3h (3.5-27.1), 7.4h (1.3-23.8) in HMP. Of the 106 kidney pairs, there was no difference in delayed graft function (36% in both groups), primary nonfunction (2.8% in HMPO vs 4.7% in HMP, p=0.48) and patient death (6.6% in HMPO vs 7.5% in HMP, p=0.88). Graft loss was significantly lower in HMPO (2.8% vs 10.4%, p=0.021). 83 pairs were eligible for primary analysis (intention-to-treat) (23 all-cause graft failures of one or both kidneys excluded). 1y-eGFR was similar in HMPO and HMP (mean(SE): 50.5(2.1) vs 46.7(1.8) mL/min/1.73m², p=0.12). However, sensitivity analysis, accounting for allcause graft failure, showed a higher 1y-eGFR in HMPO (47.6(1.9) vs 42.6(2.0) mL/min/1.73m², p=0.035). CONCLUSION : This first randomised controlled trial suggests that HMPO improves 1-year kidney graft function when accounting for the beneficial effect on graft survival.
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Jochmans, I., Hofker, H., Davies, L., Monbaliu, D., Darius, T., Mikhalski, D., Pipeleers, L., Weekers, L., Ysebaert, D., Randon, C., Knight, S., Ploeg, R., & Pirenne, J. (2019). Oxygenated Hypothermic Machine Perfusion Of Kidneys Donated After Circulatory Death: An International Randomised Controlled Trial. 26th BTS Annual Congress 2019, Antwerp, Belgium. https://hdl.handle.net/2078.5/31059