None listed
Conditions
Brief summary
There is an ongoing shortage of suitable organs for transplantation, and as a result we are using more marginal/suboptimal donor kidneys, which tend to have inferior short and longer term outcomes. Technologies exist that can potentially improve the outcomes of such kidneys by reducing the injury that occurs to these kidneys during transportation/storage prior to transplantation. One such technology is oxygenated hypothermic machine perfusion (HMP). This technology is very commonly utilised overseas, and is also currently being used in Australia (in Brisbane and Melbourne). However, the evidence for HMP efficacy in Australasia is currently lacking, and overseas results are not necessarily translatable given we tend to have shorter preservation times in Australia compared to overseas. We aim to investigate the impacts of this technology in our local setting, comparing short duration of HMP to a more prolonged duration of HMP in kidney transplantation. We will initially perform a pilot study with 20 patients, but hope to expand this into a larger scale clinical trial at the conclusion of the current study.
Interventions
Continuous oxygenated hypothermic machine perfusion (HMP) of the kidney prior to transplantation - long duration
Patients will be eligible for this arm of the study if their kidney transplant is anticipated to be reperfused after 1900 hours on the same day - in this case it will be left on HMP until 0800 the following day
This will be performed using the Kidney Assist Transporter Device (XVIVO)
The temperature will be maintained between 1-5 degrees C
The perfusion pressure will be set to 25 mmHg
Continuous oxygenated hypothermic machine perfusion (HMP) of the kidney prior to transplantation - long duration Patients will be eligible for this arm of the study if their kidney transplant is anticipated to be reperfused after 1900 hours on the same day - in this case it will be left on HMP until 0800 the following day This will be performed using the Kidney Assist Transporter Device (XVIVO) The temperature will be maintained between 1-5 degrees C The perfusion pressure will be set to 25 mmHg Oxygen (100%) will be delivered at 100 ml/min Perfusion will be commenced at the organ retrieval centre and continued until the patient is ready for transplant, and their iliac vessels have been dissected out The retrieval surgeon will connect the kidney to the perfusion device, and along with a transplant perfusionist, will monitor it remotely during the period of perfusion Device analytics will be accessed to obtain a summary of the overall perfusion record, including perfusion pressures and resistance
Sponsors
Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
o All deceased donor kidneys (DCD or DBD) that are deemed suitable for transplantation o All suitable recipients who are more than or equal to 18 years, and undergoing their first or second kidney transplant o Organ donation in NSW, with involvement of the Westmead retrieval team o All recipients who are able to provide informed consent o In a paired kidney donation (i.e. both kidneys from the same donor are allocated for transplantation at Westmead), only a single kidney will be taken for HMP, and the contralateral kidney will undergo standard cold static storage (CS) alone prior to transplantation.
Exclusion criteria
o Multi-organ transplantation (e.g. simultaneous pancreas kidney transplantation, or dual kidney transplantation) o Unable to place kidney on HMP device for any reason (e.g. technically unable to cannulate without significant leakage in system)
Outcome results
None listed