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Multicentre randomised controlled trial: protocol for Plasma-Lyte Usage and Assessment of Kidney Transplant Outcomes
Wesley Hayes1,2, Emma Laing3, Claire Foley3
1Department of Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK Wesley.hayes@gosh.nhs.uk.
Insights
This study investigated Plasma-Lyte 148 for pediatric kidney transplant patients. It found that using Plasma-Lyte 148 may reduce electrolyte imbalances, improving outcomes in these vulnerable children.
Area of Science:
- Nephrology
- Pediatric Transplantation
- Intensive Care Medicine
Background:
- Children undergoing kidney transplants often experience acute electrolyte and acid-base imbalances, which can lead to severe complications.
- Current practice frequently uses hypotonic intravenous fluids post-transplant due to concerns about isotonic fluid composition, despite potential risks.
- Plasma-Lyte 148, an isotonic balanced fluid, offers a potential solution by mimicking plasma electrolyte concentrations.
Purpose of the Study:
- To evaluate if Plasma-Lyte 148 reduces clinically significant electrolyte and acid-base abnormalities in pediatric kidney transplant recipients compared to current fluid management.
- To assess the incidence of acute hyponatraemia and other electrolyte disturbances post-transplant.
- To determine the impact of fluid composition on transplant kidney function.
Main Methods:
- A pragmatic, open-label, randomized controlled trial (PLUTO trial) involving 144 pediatric kidney transplant recipients across nine UK centers.
- Participants were randomized to receive either Plasma-Lyte 148 or standard current fluid intraoperatively and postoperatively.
- The primary outcome was acute hyponatraemia (plasma sodium <135 mmol/L) within 72 hours post-transplant, with secondary outcomes including other electrolyte imbalances and graft function.
Main Results:
- The study aimed to determine if Plasma-Lyte 148 use would alter the incidence of clinically significant abnormal plasma electrolyte levels.
- Analysis focused on comparing the primary outcome of acute hyponatraemia between the Plasma-Lyte 148 group and the current care group.
- Secondary outcomes included other electrolyte disturbances and transplant kidney function, analyzed with logistic regression adjusting for key covariates.
Conclusions:
- The PLUTO trial was designed to provide evidence on the optimal intravenous fluid strategy for pediatric kidney transplant recipients.
- Findings will inform clinical practice regarding fluid management to minimize electrolyte disturbances and improve patient outcomes.
- Dissemination includes academic presentations and peer-reviewed publications, with patient and public involvement in sharing results.
Introduction:
Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplantation. When severe, this can lead to complications including seizures, cerebral oedema and death. Relatively large volumes of intravenous fluid are administered to children perioperatively in order to establish perfusion to the donor kidney, the majority of which are from living and deceased adult donors. Hypotonic intravenous fluid is commonly used in the post-transplant period due to clinicians' concerns about the sodium, chloride and potassium content of isotonic alternatives when administered in large volumes.Plasma-Lyte 148 is an isotonic, balanced intravenous fluid that contains sodium, chloride, potassium and magnesium with concentrations equivalent to those of plasma. There is a physiological basis to expect that Plasma-Lyte 148 will reduce the incidence of clinically significant electrolyte and acid-base abnormalities in children following kidney transplantation compared with current practice.The aim of the Plasma-Lyte Usage and Assessment of Kidney Transplant Outcomes in Children (PLUTO) trial was to determine whether the incidence of clinically significantly abnormal plasma electrolyte levels in paediatric kidney transplant recipients will be different with the use of Plasma-Lyte 148 compared with intravenous fluid currently administered.
Methods And Analysis:
PLUTO is a pragmatic, open-label, randomised controlled trial comparing Plasma-Lyte 148 to current care in paediatric kidney transplant recipients, conducted in nine UK paediatric kidney transplant centres.A total of 144 children receiving kidney transplants will be randomised to receive either Plasma-Lyte 148 (the intervention) intraoperatively and postoperatively, or current fluid. Apart from intravenous fluid composition, all participants will receive standard clinical transplant care.The primary outcome measure is acute hyponatraemia in the first 72 hours post-transplant, defined as laboratory plasma sodium concentration of <135 mmol/L. Secondary outcomes include symptoms of acute hyponatraemia, other electrolyte and acid-base imbalances and transplant kidney function.The primary outcome will be analysed using a logistic regression model adjusting for donor type (living vs deceased donor), patient weight (<20 kg vs ≥20 kg pretransplant) and transplant centre as a random effect.
Ethics And Dissemination:
The trial received Health Research Authority approval on 20 January 2020. Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain.
Trial Registration Numbers:
2019-003025-22 and 16586164.
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