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

Authors

• Fran Balamuth, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
• Scott L. Weiss, Division of Critical Care, Department of Pediatrics, Nemours Children's Hospital, Wilmington, DE.
• Elliot Long, Emergency Department, Royal Children's Hospital, Parkville, VIC, Australia.
• Graham C. Thompson, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
• Amanda S. Artis, Department of Biomedical and Health Informatics, Data Science and Biostatistics Unit, Children's Hospital of Philadelphia, Philadelphia.
• Atzael B. Campos, Department of Biomedical and Health Informatics, Clinical Reporting Unit, Children's Hospital of Philadelphia, Philadelphia.
• Meredith L. Borland, Department of Emergency Medicine, Perth Children's Hospital, Nedlands, WA, Australia.
• Stuart R. Dalziel, Departments of Surgery and Pediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
• Adriana Yock-Corrales, Department of Emergency Medicine, Hospital Nacional de Niños Dr. Carlos Sáenz Herrera, Caja Costarricense del Seguro Social, San José, Costa Rica.
• Ruchi Singh, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
• Amanda Williams, Murdoch Children's Research Institute, Parkville, VIC, Australia.
• Beata Mickiewicz, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Canada.
• Christopher P. Hickey, Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia.
• Julie C. Fitzgerald, Children's Hospital of Philadelphia Pediatric Sepsis Program, Philadelphia.
• Benjamin L. Laskin, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
• Robert W. Hickey, Division of Pediatric Emergency Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh.
• Michelle Eckerle, Department of Pediatrics, University of Cincinnati College of Medicine and Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati.
• Waleed Alqurashi, Children's Hospital of Eastern Ontario, Ottawa.
• Elizabeth Alpern, Division 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 Ambroggio, Section of Pediatric Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado and the Department of Pediatrics, University of Colorado Anschutz School of Medicine, Aurora.
• Mohamed Badawy, Division of Pediatric Emergency Medicine, Department of Pediatrics, University of Texas Southwestern Medical Center, Children's Medical Center, Dallas.
• Shannon Baumer-Mouradian, Department of Pediatrics, Medical College of Wisconsin and Children's Wisconsin, Milwaukee.
• Simon Berthelot, Département 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. Clukies, Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis.
• Simon Craig, Paediatric Emergency Department, Monash Medical Centre, Melbourne, VIC, Australia.
• Sarah J. Curtis, Division of Pediatric Emergency Medicine, Department of Pediatrics, University of Alberta Stollery Children's Hospital, Edmonton, Canada.
• Adrienne L. Davis, Division of Emergency Medicine, Department of Pediatrics, Hospital for Sick Children and the Department of Paediatrics, University of Toronto, Toronto.
• Susan Duffy, Hasbro Children's Hospital, Brown University Health, Providence, RI.
• Matthew A. Eisenberg, Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Boston.
• Jason G. Emsley, IWK Health Centre and Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Faculty of Medicine, Dalhousie University, Halifax NS, Canada.
• Ara Festekjian, Division of Emergency and Transport Medicine, Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles.
• Shane George, Department of Emergency Medicine and Children's Critical Care, Gold Coast University Hospital, Southport, QLD, Australia.

Document Type

Journal Article

Publication Date

4-24-2026

Journal

The New England journal of medicine

DOI

10.1056/NEJMoa2601969

Abstract

BACKGROUND: Whether treatment with balanced crystalloid fluid leads to better outcomes than 0.9% saline in children treated for septic shock is debated. METHODS: In 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. RESULTS: Of 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. CONCLUSIONS: Among 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.).

APA Citation

Balamuth, Fran; Weiss, Scott L.; Long, Elliot; Thompson, Graham C.; Artis, Amanda S.; Campos, Atzael B.; Borland, Meredith L.; Dalziel, Stuart R.; Yock-Corrales, Adriana; Singh, Ruchi; Williams, Amanda; Mickiewicz, Beata; Hickey, Christopher P.; Fitzgerald, Julie C.; Laskin, Benjamin L.; Hickey, Robert W.; Eckerle, Michelle; Alqurashi, Waleed; Alpern, Elizabeth; Ambroggio, Lilliam; Badawy, Mohamed; Baumer-Mouradian, Shannon; Berthelot, Simon; Clukies, Lindsay D.; Craig, Simon; Curtis, Sarah J.; Davis, Adrienne L.; Duffy, Susan; Eisenberg, Matthew A.; Emsley, Jason G.; Festekjian, Ara; and George, Shane, "Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock" (2026). GW Authored Works. Paper 9019.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/9019

Department

Pediatrics