Evidence map›Paper›PMID 42028918›Full record

Trial reportThe New England journal of medicine2026

Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.

Fran Balamuth, Scott L Weiss, Elliot Long, Graham C Thompson, Amanda S Artis, Atzael B Campos, Meredith L Borland, Stuart R Dalziel, Adriana Yock-Corrales, Ruchi Singh and 53 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2026. 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 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04102371 phase3completednot on this map

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2020 to 2026Enrolled9,041ConditionsShock, SepticArmsLactated Ringer, Normal Saline, Plasma-lyte
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

63 authors.

Fran BalamuthDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
Scott L WeissDivision of Critical Care, Department of Pediatrics, Nemours Children's Hospital, Wilmington, DE.ORCID 0000-0002-7040-3281
Elliot LongEmergency Department, Royal Children's Hospital, Parkville, VIC, Australia.
Graham C ThompsonDepartments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.ORCID 0000-0002-6781-4186
Amanda S ArtisDepartment of Biomedical and Health Informatics, Data Science and Biostatistics Unit, Children's Hospital of Philadelphia, Philadelphia.
Atzael B CamposDepartment of Biomedical and Health Informatics, Clinical Reporting Unit, Children's Hospital of Philadelphia, Philadelphia.
Meredith L BorlandDepartment of Emergency Medicine, Perth Children's Hospital, Nedlands, WA, Australia.
Stuart R DalzielDepartments of Surgery and Pediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
Adriana Yock-CorralesDepartment of Emergency Medicine, Hospital Nacional de Niños Dr. Carlos Sáenz Herrera, Caja Costarricense del Seguro Social, San José, Costa Rica.
Ruchi SinghDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
Amanda WilliamsMurdoch Children's Research Institute, Parkville, VIC, Australia.
Beata MickiewiczDepartments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Christopher P HickeyChildren's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia.
Julie C FitzgeraldChildren's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia.
Benjamin L LaskinDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
Robert W HickeyDivision of Pediatric Emergency Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh.
Michelle EckerleDepartment of Pediatrics, University of Cincinnati College of Medicine and Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati.
Waleed AlqurashiChildren's Hospital of Eastern Ontario, Ottawa.ORCID 0000-0001-9772-5291
Elizabeth AlpernDivision of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago.
Lilliam AmbroggioSection of Pediatric Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado and the Department of Pediatrics, University of Colorado Anschutz School of Medicine, Aurora.ORCID 0000-0002-6242-607X
Mohamed BadawyDivision of Pediatric Emergency Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Children's Medical Center, Dallas.
Shannon Baumer-MouradianDepartment of Pediatrics, Medical College of Wisconsin and Children's Wisconsin, Milwaukee.
Simon BerthelotDépartement de Médecine de Famille et de Médecine d'Urgence, Faculté de Médecine, Université Laval et Axe Santé des Populations et Pratiques Optimales en Santé, Centre de Recherche du CHU de Québec-Université Laval, Quebec, QC, Canada.
Lindsay D ClukiesDivision of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis.
Simon CraigPaediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.
Sarah J CurtisDivision of Pediatric Emergency Medicine, Department of Pediatrics, University of Alberta Stollery Children's Hospital, Edmonton, Canada.
Adrienne L DavisDivision of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and the Department of Paediatrics, University of Toronto, Toronto.
Susan DuffyHasbro Children's Hospital, Brown University Health, Providence, RI.
Matthew A EisenbergDivision of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Boston.
Jason G EmsleyIWK Health Centre and Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, Dalhousie University, Halifax NS, Canada.
Ara FestekjianDivision of Emergency and Transport Medicine, Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles.
Shane GeorgeDepartment of Emergency Medicine and Children's Critical Care, Gold Coast University Hospital, Southport, QLD, Australia.
Rebecca GreenDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
Karen E GrippSection of Pediatric Emergency Medicine, Department of Pediatrics and Child Health, Health Sciences Center Winnipeg Children's Hospital, Winnipeg, MB, Canada.
Priya G JainDivision of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago.
Shefali JaniDepartment of Emergency Medicine, Children's Hospital at Westmead, Westmead, NSW, Australia.
Gary I JoubertLondon Health Sciences Centre and Division of Emergency Medicine, Department of Paediatrics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Canada.
Pavan JudgeBritish Columbia Children's Hospital, Department of Pediatrics, Division of Pediatric Emergency Medicine, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
April KamMcMaster Children's Hospital and Division of Emergency Medicine, Department of Pediatrics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Amit KocharDepartment of Emergency Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.
Ioannis KoutroulisDivision of Emergency Medicine, Department of Pediatrics, Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.
Maria Y KwokDepartment of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York-Presbyterian Morgan Stanley Children's Hospital, New York.
Roni D LaneDivision of Pediatric Emergency Medicine, Primary Children's Hospital, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.
Anna LithgowDepartment of Paediatrics, Royal Darwin Hospital, Tiwi, NT, Australia.
Julia LloydDivision of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus.
Karim MansourDivision of Pediatric Emergency Medicine, Department of Emergency Medicine, University of California San Francisco Benioff Children's Hospitals, Oakland.
Julie K McManemyDivision of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital and the Department of Pediatrics, Baylor College of Medicine, Houston.
Claudia MorrisDivision of Pediatric Emergency Medicine, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta.
Natalie PhillipsEmergency Department, Queensland Children's Hospital, South Brisbane, Australia.
Arjun RaoDepartment of Emergency Medicine, Sydney Children's Hospital, Randwick, NSW, Australia.
Alexander RogersDepartments of Emergency Medicine and Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor.
Anupam SehgalKingston Health Sciences Centre and Department of Pediatrics, School of Medicine, Faculty of Health Sciences, Queen's University, Kingston, ON, Canada.
Yasaman ShayanCentre Hospitalier Universitaire Sainte Justine et Département de Pédiatrie, Université de Montréal, Montreal.
Jonathan SilvermanDivision of Pediatric Emergency Medicine, Department of Emergency Medicine, Division of Critical Care, Department of Pediatrics, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond.
Eunicia TanMiddlemore Hospital, Auckland, New Zealand.
Neil G UspalUniversity of Washington, Pediatric Emergency Medicine, Seattle Children's Hospital, Seattle.
Cheryl VanceUniversity of California at Davis Children's Hospital and School of Medicine, Sacramento.
Emma WhyteEmergency Department, Townsville University Hospital, Douglas, QLD, Australia.
Jing HuangDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Stephen B FreedmanSections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.ORCID 0000-0003-2319-6192
Franz E BablEmergency Department, Royal Children's Hospital, Parkville, VIC, Australia.
Nathan KuppermannDivision of Emergency Medicine, Department of Pediatrics, Children's National Hospital and George Washington University School of Medicine and Health Sciences, Washington, DC.
PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks

Funding

Research Project Core 2P50DK114786 · NIDDK · CHILDREN'S HOSP OF PHILADELPHIA · PI Michelle Denburg · 2017 to 2026
$9.6M
PROMPT BOLUS admin supplementR01HD101528 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI BALAMUTH, FRANCES B, WEISS, SCOTT L · 2020 to 2024
$4.8M
Finding Appropriate Subtypes in a Trial of Balanced versus nOrmaL Saline FlUid in SepsisR01GM145698 · NIGMS · CHILDREN'S HOSP OF PHILADELPHIA · PI YEHYA, NADIR · 2022 to 2025
$2.6M
CIHR 173498Eunice Kennedy Shriver National Institute of Child Health and Human Development R01HD101528National Health and Medical Research Council GNT1190814NICHD NIH HHS R01 HD101528NIDDK NIH HHS P50 DK114786NIDDK NIH HHS P50DK114786NIGMS NIH HHS R01 GM145698NIGMS NIH HHS R01GM145698Pennsylvania Department of Health SAP #4100085749
6 · The paper itself

Abstract

backgroundWhether treatment with balanced crystalloid fluid leads to better outcomes than 0.9% saline in children treated for septic shock is debated.

methodsIn this pragmatic clinical trial conducted at 47 emergency departments in five countries, patients (2 months to <18 years of age) with suspected septic shock and abnormal perfusion were randomly assigned to receive fluid resuscitation with either balanced fluid or 0.9% saline for up to 48 hours. The primary outcome was a major adverse kidney event (a composite of death, new renal-replacement therapy, or persistent kidney dysfunction) at 30 days after enrollment or hospital discharge, whichever occurred first.

resultsOf 9041 enrolled patients, 277 (6.1%) in the balanced-fluid group and 282 (6.2%) in the 0.9%-saline group withdrew from the trial, leaving 4235 and 4247 patients, respectively, for analysis. A primary-outcome event occurred in 137 patients (3.4%) in the balanced-fluid group and in 124 (3.0%) in the 0.9%-saline group (difference, 0.4 percentage points; 95% confidence interval [CI], -0.5 to 1.3; risk ratio, 1.10; 95% CI, 0.88 to 1.40; P = 0.85). The median number of hospital-free days during 28 days after enrollment was 23 (interquartile range, 19 to 25) in both groups. Hyperchloremia occurred in 868 patients (31.4%) in the balanced-fluid group and in 1383 (49.0%) in the 0.9%-saline group; hypernatremia in 52 (1.8%) and 89 (3.1%), respectively; and hyperlactatemia in 260 (19.8%) and 228 (16.7%). No differences in other safety outcomes or adverse events were seen.

conclusionsAmong children treated for septic shock, no significant difference was seen in the incidence of death, new renal-replacement therapy, or persistent kidney dysfunction when fluid resuscitation was administered with balanced fluid as compared with 0.9% saline. (Funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; PRoMPT BOLUS ClinicalTrials.gov number, NCT04102371.).

Indexed as

Crystalloid SolutionsFluid TherapySaline SolutionShock, SepticAcute Kidney InjuryAdolescentChildChild, PreschoolCreatinineFemaleHumansInfantIsotonic SolutionsMaleRenal Insufficiency, ChronicRenal Replacement TherapyCreatinineCrystalloid SolutionsIsotonic SolutionsSaline Solution

Identifiers

PMID42028918
PMCPMC13134814

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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.