Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function. Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.
Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion. Continuous HMP using the XVIVO Kidney Assist Transport is routinely used for deceased donor kidney preservation in the Netherlands. This is a single-center, non-randomized, uncontrolled, open-label first-in-human clinical investigation evaluating Omnisol as an organ preservation solution for continuous HMP of deceased donor kidneys before transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Omnisol for HMP of deceased donor kidneys
Erasmus Medical Center
Rotterdam, Netherlands
RECRUITINGIncidence of Delayed Graft Function
Incidence of delayed graft function, defined as the need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalemia or volume overload.
Time frame: Within 7 days post-transplantation.
Graft Survival
30-day graft survival (censored and uncensored for recipient death).
Time frame: 30 days post-transplantation.
Graft Survival
Graft survival (censored and uncensored for recipient death).
Time frame: 3, 6 and 12 months post-transplantation.
Recipient survival
Rate of recipient survival.
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
Kidney Graft Function Assessed by eGFR
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.
Time frame: 30 days, 3, 6 and 12 months post-transplantation.
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