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PRoMPT BOLUS; fluids for treating shock, the evidence builds

archdischild · 2026-05-18 · canonical JSON source

15 visible annotations · policy: published · automated confidence ≥ 75.00%

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Does resuscitation and maintenance hydration with balanced fluid (such as such as lactated Ringer’s solution or Plasma-Lyte) lead to a lower incidence of major adverse kidney events within 30 days than that with 0.9% saline. What a great piece of work. Networking at its best to get sufficient numbers in a study to ask fundamental questions. Three large, paediatric emergency medicine (PEM) research networks working together for this simple question. Balamuth F et al [NEJM 2026 DOI: 10.1056/NEJMoa2601969] have examined treatment with balanced crystalloid fluid to see if it leads to better outcomes than 0.9% saline in children treated for septic shock in the Pragmatic Paediatric Trial of Balanced vs Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study. This was a clinical trial conducted at 47 emergency departments in five countries. Children aged between 2 months to<18 years of age with suspected septic shock and abnormal perfusion were recruited. They were randomly assigned to receive fluid resuscitation with either balanced fluid or 0.9% saline for up to 48 hours. Of the 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 for analysis. A primary-outcome event [which was defined as a major adverse kidney event (a composite of death, new renal-replacement therapy, or persistent kidney dysfunction) at 30 days after enrolment or hospital discharge] 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% CI (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 enrolment was 23 (IQR, 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. So, the evidence builds, in children treated for septic shock there was no significant difference 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. Archivist admires the magnificent trial management and research governance efforts of the Paediatric Emergency Care Applied Research Network (PECARN) in the United States, the Paediatric Emergency Research Canada (PERC) network in Canada, the Paediatric Research in Emergency Departments International Collaborative (PREDICT) in Australia and New Zealand, and in Costa Rica. The Surviving Sepsis Campaign has a conditional recommendation for treatment with balanced fluids over 0.9% saline in children with septic shock (Weiss SL et al [ Pediatr Crit Care Med 2026;27:379-434]) and there is no doubt, from previous studies, that balanced fluid treatment results in a lower incidence of hyperchloremia and hypernatremia compared with treatment with 0.9% saline but this large study shows that these biochemical effects did not translate to improved patient-centred outcomes.