Transplant Trial Watch

Cold Pulsatile Machine Perfusion Versus Static Cold Storage for Kidneys Donated After Circulatory Death: A Multicenter Randomized Controlled Trial.

Summers, D. M., et al.

Transplantation 2020; 104(5): 1019-1025.


Aims
The aim of this study was to investigate whether cold pulsatile machine perfusion (MP) leads to lower incidence of delayed graft function (DGF) compared to static cold storage in recipients of donation after circulatory death (DCD) kidneys.

Interventions
DCD kidneys were randomized to either the cold pulsatile MP group or the static cold storage group.

Participants
102 kidney transplant recipients.

Outcomes
The primary outcome was DGF. The secondary outcomes were estimated glomerular filtration rate (eGFR), serum creatinine levels, slow graft function, biopsy proven acute rejection rate, whether the recipient was dialysis-free at 30 days following transplant, death censored graft survival, patient survival and duration of hospital stay.

Follow-up
12 months

CET Conclusions
This interesting multicentre RCT from the UK investigates the use of “device-to-donor” hypothermic machine preservation (HMP) of DCD kidneys compared to static cold storage. The study uses an unblinded paired-kidney design, allocating kidneys from each donor to alternative groups. The authors found no difference in the rate of DGF between groups, with improved 3-month but not 12-month renal function in recipients. These results differ from previous large RCTs of HMP, which have shown significant reductions in DGF rates with machine preservation. As the authors note, the current study is underpowered due to recruitment issues stemming from changes in allocation and practice around DCD kidneys. Whilst overall CIT is provided in the manuscript, the duration of machine preservation in the MP arm is not reported, and differences in duration may play a role in efficacy.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ISRCTN50082383

Funding source
Non-industry funded