Introduction: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous nonrandomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established.
Methods and analysis:This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function.
Ethics and dissemination:The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals.Registration: registered in clinicaltrials.gov (NCT04882254).
Highlights:• This is the first RCT to compare additional NMP to HMP alone.• Extensive sampling will offer in-depth analysis of kidney physiology during NMP.• This RCT may help identify biomarkers to predict clinical outcomes during NMP.• Biomarkers can help develop NMP as assessment tool for declined kidneys.
Background: Little is known about the influence of the duration of the kidney back-table preparation period and kidney temperature on graft outcomes after transplantation. The aim of this study is to investigate the back-table duration and its relation to graft outcome and the relation between kidney temperature and graft outcome. Methods: In this prospective cohort study, deceased donor kidney temperature is measured at fixed time points using an infrared thermometer during back-table preparation and transplantation. Additionally, the back-table duration is measured using a timer. Results: Between September 2020 and July 2021, 49 kidneys were prospectively included in this study. Median back-table duration was 33.7 (standard deviation ± 14.1) min and donor kidney temperature increased up to 14.9 °C (±2.8) after 60 min of back-table preparation. Mean implantation time was 24.9 (±7.6) min and kidney temperature increased up to 25.9 °C (±2.4) after 30 min of implantation time. Longer back-table duration was significantly associated with higher rates of delayed graft function (p = 0.037). However, this observation did not sustain at 3 and 6-months post-transplantation. No association was found between kidney temperature and graft outcomes. Conclusion: Longer back-table duration is significantly associated with DGF after deceased donor kidney transplantation. No association was observed between kidney temperature and graft outcomes of deceased donor kidneys.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.