Abstract :
[en] BACKGROUND
Static cold storage is generally used to preserve kidney allografts from deceased donors.
Hypothermic machine perfusion may improve outcomes after transplantation,
but few sufficiently powered prospective studies have addressed this possibility.
METHODS
In this international randomized, controlled trial, we randomly assigned one kidney
from 336 consecutive deceased donors to machine perfusion and the other to cold
storage. All 672 recipients were followed for 1 year. The primary end point was delayed
graft function (requiring dialysis in the first week after transplantation). Secondary
end points were the duration of delayed graft function, delayed graft function
defined by the rate of the decrease in the serum creatinine level, primary nonfunction,
the serum creatinine level and clearance, acute rejection, toxicity of the calcineurin
inhibitor, the length of hospital stay, and allograft and patient survival.
RESULTS
Machine perfusion significantly reduced the risk of delayed graft function. Delayed
graft function developed in 70 patients in the machine-perfusion group versus 89 in
the cold-storage group (adjusted odds ratio, 0.57; P = 0.01). Machine perfusion also
significantly improved the rate of the decrease in the serum creatinine level and
reduced the duration of delayed graft function. Machine perfusion was associated
with lower serum creatinine levels during the first 2 weeks after transplantation
and a reduced risk of graft failure (hazard ratio, 0.52; P = 0.03). One-year allograft
survival was superior in the machine-perfusion group (94% vs. 90%, P = 0.04). No
significant differences were observed for the other secondary end points. No serious
adverse events were directly attributable to machine perfusion.
CONCLUSIONS
Hypothermic machine perfusion was associated with a reduced risk of delayed graft
function and improved graft survival in the first year after transplantation. (Current
Controlled Trials number, ISRCTN83876362.)
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