Evidence map›Paper›PMID 21943218›Full record

Trial reportBMC pediatrics2011

A randomized controlled trial of isotonic versus hypotonic maintenance intravenous fluids in hospitalized children.

Thomas G Saba, James Fairbairn, Fiona Houghton, Diane Laforte, Bethany J Foster

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00457873 (Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT00457873 phase3completednot on this map

Isotonic Versus Hypotonic Saline for Maintenance Intravenous Fluid Therapy: A Pilot Randomized Trial

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2007 to 2008Enrolled38ConditionsGastroenteritis, Bronchiolitis, Sepsis, Urinary Tract InfectionArms0.9% saline in 5% dextrose (intravenous), 0.45% saline in 5% dextrose (intravenous)
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Hospital-acquired Hyponatremia in Pediatric Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2017
    Article
  15. Intravenous fluids: balancing solutions.Journal of nephrology · 2017
    Review
  16. Article
  17. Article
  18. Article
  19. Hospital-acquired hyponatremia in pediatric patients: a review of the literature.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2013
    Article
  20. 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

5 authors at 2 institutions in 1 country.

Thomas G SabaDept, of Pediatrics, Montreal Children's Hospital, McGill University, Montreal, QC, Canada.
James Fairbairn
Fiona Houghton
Diane Laforte
Bethany J Foster
Montreal Children's Hospital · CAMcGill University · CA

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundIsotonic saline has been proposed as a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia. However, the optimal tonicity of maintenance intravenous fluids in hospitalized children has not been determined. The objective of this study was to estimate and compare the rates of change in serum sodium ([Na]) for patients administered either hypotonic or isotonic IV fluids for maintenance needs.

methodsThis was a masked controlled trial. Randomization was stratified by admission type: medical patients and post-operative surgical patients, aged 3 months to 18 years, who required IV fluids for at least 8 hours. Patients were randomized to receive either 0.45% or 0.9% saline in 5.0% dextrose. Treating physicians used the study fluid for maintenance; infusion rate and the use of additional fluids were left to their discretion.

resultsSixteen children were randomized to 0.9% saline and 21 to 0.45% saline. Baseline characteristics, duration (average of 12 hours) and rate of study fluid infusion, and the volume of additional isotonic fluids given were similar for the two groups. [Na] increased significantly in the 0.9% group (+0.20 mmol/L/h [IQR +0.03, +0.4]; P = 0.02) and increased, but not significantly, in the 0.45% group (+0.08 mmol/L/h [IQR -0.15, +0.16]; P = 0.07). The rate of change and absolute change in serum [Na] did not differ significantly between groups.

conclusionsWhen administered at the appropriate maintenance rate and accompanied by adequate volume expansion with isotonic fluids, 0.45% saline did not result in a drop in serum sodium during the first 12 hours of fluid therapy in children without severe baseline hyponatremia. Confirmation in a larger study is strongly recommended. CLINICAL TRIAL REGISTRATION NUMBER: NCT00457873 (http://www.clinicaltrials.gov/).

Indexed as

AdolescentChildChild, PreschoolDouble-Blind MethodFemaleFluid TherapyHospitalizationHumansHyponatremiaHypotonic SolutionsInfantIsotonic SolutionsMaleProspective StudiesSodiumSodium ChlorideHypotonic SolutionsIsotonic SolutionsSodiumSodium Chloride

Identifiers

PMID21943218
PMCPMC3187723
OpenAlexW2143019494

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.