A pragmatic, open-label, randomized controlled trial of Plasma-Lyte-148 versus standard intravenous fluids in children receiving kidney transplants (PLUTO).

Abstract

Acute electrolyte and acid-base imbalance is experienced by many children following kidney transplant. This is partly because doctors give very large volumes of artificial fluids to keep the new kidney working. When severe, fluid imbalance can lead to seizures, cerebral edema and death. In this pragmatic, open-label, randomized controlled trial, we randomly assigned (1:1) pediatric kidney transplant recipients to Plasma-Lyte-148 or standard of care perioperative intravenous fluids (predominantly 0.45% sodium chloride and 0.9% sodium chloride solutions). We then compared clinically significant electrolyte and acid-base abnormalities in the first 72 hours post-transplant. The primary outcome, acute hyponatremia, was experienced by 53% of 68 participants in the Plasma-Lyte-148 group and 58% of 69 participants in the standard fluids group (odds ratio 0·77 (0·34 - 1·75)). Five of 16 secondary outcomes differed with Plasma-Lyte-148: hypernatremia was significantly more frequent (odds ratio 3·5 (1·1 - 10·8)), significantly fewer changes to fluid prescriptions were made (rate ratio 0·52 (0·40-0·67)), and significantly fewer participants experienced hyperchloremia (odds ratio 0·17 (0·07 - 0·40)), acidosis (odds ratio 0·09 (0·04 - 0·22)) and hypomagnesemia (odds ratio 0·21 (0·08 - 0·50)). No other secondary outcomes differed between groups. Serious adverse events were reported in 9% of participants randomized to Plasma-Lyte-148 and 7% of participants randomized to standard fluids. Thus, perioperative Plasma-Lyte-148 did not change the proportion of children who experienced acute hyponatremia compared to standard fluids. However fewer fluid prescription changes were made with Plasma-Lyte-148, while hyperchloremia and acidosis were less common.

• Authors: Wesley N Hayes, Emma Laing, Rosemary Brown, Laura Silsby, Laura Smith, Helen Thomas, Fotini Kaloyirou, Rupa Sharma, James Griffiths, Helen Hume-Smith, Stephen D Marks, Nicos Kessaris, Martin Christian, Jan Dudley, Mohan Shenoy, Michal Malina, Mordi Muorah, Nicholas Ware, Pallavi Yadav, Ben Reynolds, William Bryant, Anastassia Spiridou, Jo Wray, Mark J Peters
• Journal: Kidney international (Kidney Int) (Oct 31 2023) ISSN: 1523-1755 [Electronic] United States
• PMID: 37914088 (Publication Type: Journal Article)
• Copyright: Copyright © 2023 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.