Historical collection · First published Apr 23, 2026; added to EM Weekly Oct 27, 2026. This retrospective summary may be superseded by later evidence or guidance.

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Randomized trialNew England Journal of Medicine

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

First online Apr 23, 2026On EM Weekly Oct 27, 2026Discovered Oct 27, 2026AI-generated Not yet human-reviewed

Summary

In this pragmatic trial at 47 EDs, balanced fluid and saline produced similar major adverse kidney event rates in children treated for suspected septic shock. Of 9,041 enrolled, 8,482 remained for analysis after withdrawal without permission to use data.

Why it matters

Balanced fluids reduced some electrolyte abnormalities but did not demonstrate a patient-centered renal benefit. This later trial should be considered alongside the very-low-certainty preference for balanced fluids in March 2026 pediatric sepsis guidance.

Study at a glance

Design
Randomized trial
Population
Children aged two months to under 18 years with suspected septic shock and abnormal perfusion at EDs in five countries.
Sample size
8482
Intervention
Balanced crystalloids for resuscitation and maintenance for up to 48 hours.
Comparator
0.9% saline.
Primary endpoint
Death, new kidney replacement therapy, or persistent kidney dysfunction by day 30 or hospital discharge.

Main findings

  • MAKE30: 3.4% versus 3.0%; RR 1.10 (95% CI 0.88-1.40).
  • Hyperchloremia was less frequent with balanced fluids.

Limitations

Unblinded fluid assignment, missing laboratory measurements, and low primary-event frequency limit interpretation. A neutral superiority trial does not prove all fluid choices equivalent.

Read the primary source

Full text: Open-access full text available.

Original source

DOI: 10.1056/NEJMoa2601969

PMID: 42028918

Source retrieved Oct 27, 2026. Indexed legal PMC13134814 abstract and selected methods reviewed, not complete full text. Publisher History explicitly gives April 23 online publication; PubMed/manuscript date April 24 was not used as first-online. Publisher title uses “or”; manuscript title uses “versus”.

Corrections & review history

No corrections recorded. Human review: not yet human-reviewed.