0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial

Abstract Background Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plas...

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Main Authors: Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons, Luregn J. Schlapbach
Format: Article
Language:English
Published: BMC 2021-07-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-021-05376-5
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spelling doaj-95bbc68464294b5ebd45d65f981d10b52021-07-04T11:39:47ZengBMCTrials1745-62152021-07-0122111010.1186/s13063-021-05376-50.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trialSainath Raman0Andreas Schibler1Renate Le Marsney2Peter Trnka3Melanie Kennedy4Adrian Mattke5Kristen Gibbons6Luregn J. Schlapbach7Paediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Nephrology, Queensland Children’s HospitalPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandPaediatric Critical Care Research Group, Child Health Research Centre, The University of QueenslandAbstract Background Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plasma-Lyte 148 and Compound Sodium Lactate, represent potential alternatives but the evidence on optimal fluid choices in critically ill children remains scarce. This study aims to demonstrate whether balanced solutions, when used as intravenous fluid therapy, are able to reduce the incidence of a rise in serum chloride level compared to 0.9% sodium chloride in critically ill children. Methods This is a single-centre, open-label randomized controlled trial with parallel 1:1:1 assignment into three groups: 0.9% sodium chloride, Plasma-Lyte 148, and Compound Sodium Lactate solutions for intravenous fluid therapy. The intervention includes both maintenance and bolus fluid therapy. Children aged < 16 years admitted to intensive care and receiving intravenous fluid therapy during the first 4 h of admission are eligible. The primary outcome measure is a ≥ 5mmol/L increase in serum chloride level within 48 h post-randomization. The enrolment target is 480 patients. The main analyses will be intention-to-treat. Discussion This study tests three types of intravenous fluid therapy in order to compare the risk of hyperchloremia associated with normal saline versus balanced solutions. This pragmatic study is thereby assessing the most common intervention in paediatric critical care. This is a single-centre open-label study with no blinding at the level of delivery of the intervention. Certain paediatric intensive care unit (PICU) patient groups such as those admitted with a cardiac condition or following a traumatic brain injury are excluded from this study. Trial registration The study has received ethical approval (HREC/19/QCHQ/53177: 06/06/2019). It is registered in the Australian New Zealand Clinical Trials Registry ( ACTRN12619001244190 ) from 9th September 2019. Recruitment commenced on 12th November 2019. The primary results manuscript will be published in a peer-reviewed journal.https://doi.org/10.1186/s13063-021-05376-5Balanced solutionsBolusChildCritical careIntravenous fluid therapy
collection DOAJ
language English
format Article
sources DOAJ
author Sainath Raman
Andreas Schibler
Renate Le Marsney
Peter Trnka
Melanie Kennedy
Adrian Mattke
Kristen Gibbons
Luregn J. Schlapbach
spellingShingle Sainath Raman
Andreas Schibler
Renate Le Marsney
Peter Trnka
Melanie Kennedy
Adrian Mattke
Kristen Gibbons
Luregn J. Schlapbach
0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
Trials
Balanced solutions
Bolus
Child
Critical care
Intravenous fluid therapy
author_facet Sainath Raman
Andreas Schibler
Renate Le Marsney
Peter Trnka
Melanie Kennedy
Adrian Mattke
Kristen Gibbons
Luregn J. Schlapbach
author_sort Sainath Raman
title 0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
title_short 0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
title_full 0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
title_fullStr 0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
title_full_unstemmed 0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial
title_sort 0.9% sodium chloride solution versus plasma-lyte 148 versus compound sodium lactate solution in children admitted to picu—a randomized controlled trial (splyt-p): study protocol for an intravenous fluid therapy trial
publisher BMC
series Trials
issn 1745-6215
publishDate 2021-07-01
description Abstract Background Intravenous fluid therapy represents the most common intervention critically ill patients are exposed to. Hyperchloremia and metabolic acidosis associated with 0.9% sodium chloride have been observed to lead to worse outcomes, including mortality. Balanced solutions, such as Plasma-Lyte 148 and Compound Sodium Lactate, represent potential alternatives but the evidence on optimal fluid choices in critically ill children remains scarce. This study aims to demonstrate whether balanced solutions, when used as intravenous fluid therapy, are able to reduce the incidence of a rise in serum chloride level compared to 0.9% sodium chloride in critically ill children. Methods This is a single-centre, open-label randomized controlled trial with parallel 1:1:1 assignment into three groups: 0.9% sodium chloride, Plasma-Lyte 148, and Compound Sodium Lactate solutions for intravenous fluid therapy. The intervention includes both maintenance and bolus fluid therapy. Children aged < 16 years admitted to intensive care and receiving intravenous fluid therapy during the first 4 h of admission are eligible. The primary outcome measure is a ≥ 5mmol/L increase in serum chloride level within 48 h post-randomization. The enrolment target is 480 patients. The main analyses will be intention-to-treat. Discussion This study tests three types of intravenous fluid therapy in order to compare the risk of hyperchloremia associated with normal saline versus balanced solutions. This pragmatic study is thereby assessing the most common intervention in paediatric critical care. This is a single-centre open-label study with no blinding at the level of delivery of the intervention. Certain paediatric intensive care unit (PICU) patient groups such as those admitted with a cardiac condition or following a traumatic brain injury are excluded from this study. Trial registration The study has received ethical approval (HREC/19/QCHQ/53177: 06/06/2019). It is registered in the Australian New Zealand Clinical Trials Registry ( ACTRN12619001244190 ) from 9th September 2019. Recruitment commenced on 12th November 2019. The primary results manuscript will be published in a peer-reviewed journal.
topic Balanced solutions
Bolus
Child
Critical care
Intravenous fluid therapy
url https://doi.org/10.1186/s13063-021-05376-5
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