PLUTO
Plasma-Lyte Usage and assessment of kidney Transplant Outcomes in children
Chief investigator: Dr Wesley Hayes
Primary sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Funder: National Institute for Health Research
NHSBT Research Theme: Organ Donation and Transplantation
Summary
Kidney transplantation transforms the lives of children with severe kidney disease. It allows many to return to a life without frequent hospital visits or dialysis treatment. But the transplant itself is a big operation.
In the first few days after kidney transplant, many children develop dangerous changes in the amount of salt and water in the bloodstream. This is because doctors give very large volumes of artificial fluids into the veins to keep the new kidney working.
If the main salt in the blood (sodium) falls too far, serious problems including brain damage and even death can occur.
Because of this, we take blood samples from each child every 2-4 hours for the first day after the transplant operation to check sodium levels and change them if necessary.
Study hypothesis
This research aims to compare the standard fluid used after the transplant operation with an alternative that may reduce dangerous changes in salt levels and help the transplant kidney to work better.
The new fluid is called PlasmaLyte. It matches the normal composition of blood more closely than standard fluid.
PlasmaLyte is already used in other sick children, including those on intensive care units. Although there are good reasons to believe that PlasmaLyte may be a safer choice of fluid for children after kidney transplant, there is no evidence comparing PlasmaLyte with standard fluid for children.
We plan to work out which of the two fluids is better by looking at children’s kidney transplants in the UK, half using the standard fluid and half using the new fluid.
The choice of fluid will be made randomly by a computer. We will compare the number of children in each group who have low blood salt levels, and their kidney function. No additional blood samples will be required. Children who participate in the study will continue to have all the usual care they would otherwise receive.
Study design
National multi-centred open label randomised controlled trial.