Sepsis & infection

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

N Engl J MedPublished Randomised controlled trial

Authors' conclusion

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.

Study context

Population
Children (2 months to <18 years) with suspected septic shock and abnormal perfusion, 47 EDs in five countriesenrolled
Participants
9,041 children
Comparison
Balanced fluid vs 0.9% saline for fluid resuscitation up to 48 hours
  • Balanced fluidn = 4,235
  • 0.9% salinen = 4,247reference
Primary endpoint
Major adverse kidney event:
  • Death
  • New RRT
  • Persistent kidney dysfunction
Follow-up
30 days after enrollment or hospital discharge, whichever occurred first
Methodological detailspragmatic, multicentre, 277 (6.1%) in the balanced-fluid group and 282 (6.2%) in the 0.9%-saline group withdrew
  • Pragmatic
  • Multicentre
  • 277 (6.1%) in the balanced-fluid group and 282 (6.2%) in the 0.9%-saline group withdrew

Primary result

As reported in the abstract

Each group vs 0.9% salineDifference, percentage points (95% CI)
Balanced fluid
0.4(−0.5 to 1.3)
Each group vs 0.9% salineRelative risk (95% CI)P value
Balanced fluid
1.10(0.88–1.40)
P = 0.85

Further findings

Hospital-free days · 28 days after enrollment

Safety

Hyperchloremia

Hypernatremia

Hyperlactatemia

Other safety outcomes and adverse events

No differences seen

Original publication

Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock. N Engl J Med. Published 24 April 2026. doi:10.1056/nejmoa2601969

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