PLUTO

• Research type

  Research Study

• Full title

  PlasmaLyte Usage and assessment of kidney Transplant Outcomes in children: the PLUTO trial

• IRAS ID

  270431

• Contact name

  Wesley Hayes

• Contact email

  wesley.hayes@gosh.nhs.uk

• Sponsor organisation

  Great Ormond Street Hospital for Children NHS Foundation Trust

• Eudract number

  2019-003025-22

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  In the first few days after a 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 every 2-4 hours for the first day after the transplant operation to check sodium levels and change them if necessary.

  This research aims to compare the standard fluid used after the transplant operation with an alternative that may reduce dangerous changes in salt (sodium) levels and help the transplant kidney to work better.

  The alternative 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 standard fluid and half using PlasmaLyte. 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 transplant kidney function.

  No additional blood samples will be required. Children who participate in the study will continue to have all the usual care that they would otherwise receive.

  This study has the potential to change clinical practice and importantly improve the treatment and outcomes of children receiving kidney transplants in the UK.

• REC name

  London - Central Research Ethics Committee

• REC reference

  19/LO/1866

• Date of REC Opinion

  22 Dec 2019

• REC opinion

  Further Information Favourable Opinion