ArticleAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2019
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study.
Article in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04102371 (Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled 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.
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.
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis
Who cites it
21 citing papers in PubMed, 6 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- 2025 Korean Guidelines for Cardiopulmonary Resuscitation: Part 8. Pediatric advanced life support.Clinical and experimental emergency medicine · 2026Guideline
- Surviving Sepsis Campaign International Guidelines for the Management of Sepsis and Septic Shock in Children 2026.Intensive care medicine · 2026Pooled it
- Balanced crystalloid versus saline for resuscitation in pediatric septic shock: a systematic review and meta-analysis.BMC pediatrics · 2025Pooled it
- Fluid resuscitation in children with severe infection and septic shock: a systematic review and meta-analysis.European journal of pediatrics · 2024Pooled it
- Acetate- versus lactate-buffered crystalloid solutions: A systematic review with meta-analysis and trial sequential analysis.Acta anaesthesiologica Scandinavica · 2022Pooled it
- Balanced crystalloids versus saline in critically ill patients: The PRISMA study of a meta-analysis.Medicine · 2021Pooled it
- Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.The New England journal of medicine · 2026Trial
- Time Course of Kidney Injury Biomarkers in Children With Septic Shock: Nested Cohort Study Within the Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis Trial.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2025Trial
- Shared Decision Making for Syncope in the Emergency Department: A Randomized Controlled Feasibility Trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2020Trial
- Balanced crystalloids versus 0.9% saline for fluid resuscitation in children with septic shock: an updated systematic review and meta-analysis of randomized controlled trials.Irish journal of medical science · 2026Review
- Balanced crystalloids versus isotonic saline in pediatric sepsis: a comprehensive systematic review and meta-analysis.Proceedings (Baylor University. Medical Center) · 2024Article
- Electrolyte derangements in critically ill children receiving balanced versus unbalanced crystalloid fluid resuscitation.BMC nephrology · 2022Observational
- Pragmatic clinical trial design in emergency medicine: Study considerations and design types.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022Article
- Medication and Fluid Management of Pediatric Sepsis and Septic Shock.Paediatric drugs · 2022Review
- Article
- A pediatric perspective on World Sepsis Day in 2021: leveraging lessons from the pandemic to reduce the global pediatric sepsis burden?American journal of physiology. Lung cellular and molecular physiology · 2021Article
- Article
- The Pediatric Emergency Research Network: A Decade of Global Research Cooperation in Pediatric Emergency Care.Pediatric emergency care · 2021Article
- [Paediatric Life Support].Notfall & rettungsmedizin · 2021Review
- Pediatric Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.Resuscitation · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundResuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.
methodsOpen-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.
resultsOf 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%).
conclusionsA pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.
Indexed as
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What OpenQuestion holds
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.