Evidence map›Paper›PMID 34217337›Full record

ArticleTrials2021

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.

Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons, Luregn J Schlapbach

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.3field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Sainath RamanPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia. sainath.raman@uq.edu.au.ORCID http://orcid.org/0000-0002-0152-9980
Andreas SchiblerPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Renate Le MarsneyPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Peter TrnkaPaediatric Nephrology, Queensland Children's Hospital, South Brisbane, Australia.
Melanie KennedyPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Adrian MattkePaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Kristen GibbonsPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Luregn J SchlapbachPaediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
The University of Queensland · AUChildren's Health Queensland Hospital and Health Service · AU

Funding

Children's Health Queensland Hospital and Health Service 2731024
6 · The paper itself

Abstract

backgroundIntravenous 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.

methodsThis 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 registrationThe 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.

Indexed as

Sodium ChlorideSodium LactateAustraliaChildFluid TherapyGluconatesHumansIntensive Care Units, PediatricMagnesium ChloridePotassium ChloridePragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSodium AcetateGluconatesMagnesium ChloridePlasma-lyte 148Potassium ChlorideSodium AcetateSodium ChlorideSodium LactateBalanced solutionsBolusChildCritical careIntravenous fluid therapy

Identifiers

PMID34217337
PMCPMC8254328
OpenAlexW3152519608

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.