None listed
Conditions
Brief summary
This is a feasibility study of normothermic machine perfusion technology in human DCD kidneys deemed suitable for transplantation. If preliminary results are encouraging a larger prospective RCT will be required to confirm whether this technology improves Kidney transplant outcomes in the clinical setting. Experimental data and early non randomised clinical studies from Europe appear to show a significant benefit, by reducing the need for post transplant dialysis.
Interventions
Kidneys from donation after circulatory death donors (DCD) deemed suitable for clinical transplantation will be considered for this pilot trial. if the adult recipients provide consent, Kidneys will be perfused using a TGA approved "Kidney Assist," normothermic machine perfusion device. A minimum of one hour perfusion time will be employed directly prior to transplantation. 4 hours will be the maximum perfusion time. Blood, heparinised and oxygenated is the perfusate and requires to be removed u
Kidneys from donation after circulatory death donors (DCD) deemed suitable for clinical transplantation will be considered for this pilot trial. if the adult recipients provide consent, Kidneys will be perfused using a TGA approved "Kidney Assist," normothermic machine perfusion device. A minimum of one hour perfusion time will be employed directly prior to transplantation. 4 hours will be the maximum perfusion time. Blood, heparinised and oxygenated is the perfusate and requires to be removed using standard cold preservation solution, at the end of the perfusion period, prior to implantation. This normothermic machine perfusion intervention will be performed in the operating theatre by the principal investigator and transplant team, all of whom have completed training in the use of the Kidney assist device. In addition the PI has supervised a PhD student who has utilised this technology with discarded human kidneys, prior to this clinical trial.
Sponsors
Royal Australasian College of Surgeons
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consenting adult recipients aged over 18 years who have been allocated a DCD kidney for Transplantation at Westmead Hospital NSW. They must be able to understand the intervention which is being performed on the kidney, prior to it being transplanted into themselves and the potential complications and be able to give consent freely.
Exclusion criteria
No paediatric recipient will be included in this trial. Patients who have either mental health or communication issues, such that they cannot consent or understand the trial will also be excluded. However both of these are usually a contraindication to transplantation, if they are unable to comply with standard post transplant care. Furthermore, patients undergoing their 3rd or more transplant or multi-organ transplantation will also be excluded.
Outcome results
None listed