PubMed · 42028918
Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.
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.).
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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, Amanda Williams, Beata Mickiewicz, Christopher P Hickey, Julie C Fitzgerald, Benjamin L Laskin, Robert W Hickey, Michelle Eckerle, Waleed Alqurashi, Elizabeth Alpern, Lilliam Ambroggio, Mohamed Badawy, Shannon Baumer-Mouradian, Simon Berthelot, Lindsay D Clukies, Simon Craig, Sarah J Curtis, Adrienne L Davis, Susan Duffy, Matthew A Eisenberg, Jason G Emsley, Ara Festekjian, Shane George, Rebecca Green, Karen E Gripp, Priya G Jain, Shefali Jani, Gary I Joubert, Pavan Judge, April Kam, Amit Kochar, Ioannis Koutroulis, Maria Y Kwok, Roni D Lane, Anna Lithgow, Julia Lloyd, Karim Mansour, Julie K McManemy, Claudia Morris, Natalie Phillips, Arjun Rao, Alexander Rogers, Anupam Sehgal, Yasaman Shayan, Jonathan Silverman, Eunicia Tan, Neil G Uspal, Cheryl Vance, Emma Whyte, Jing Huang, Stephen B Freedman, Franz E Babl, Nathan Kuppermann, PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks. 2026-04-24. Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.. https://doi.org/10.1056/nejmoa2601969
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