BALANCED fluid did not reduce major adverse kidney events compared with saline in children treated for septic shock.
A large pragmatic clinical trial found no significant difference between balanced crystalloid fluid and 0.9% saline in the incidence of death, new renal replacement therapy, or persistent kidney dysfunction. The findings address continued uncertainty surrounding the preferred fluid for pediatric septic shock resuscitation.
International Trial Compares Fluid Resuscitation Strategies
The trial enrolled 9,041 children between 2 months and younger than 18 years of age who presented with suspected septic shock and abnormal perfusion. Participants were treated at 47 emergency departments across five countries and randomly assigned to receive balanced fluid or 0.9% saline for up to 48 hours.
Following trial withdrawals, the analysis included 4,235 children in the balanced fluid group and 4,247 in the saline group. The primary outcome was a major adverse kidney event within 30 days of enrollment or by hospital discharge, whichever occurred first. This composite outcome included death, newly initiated renal replacement therapy, or persistent kidney dysfunction.
Kidney Outcomes Remain Similar Between Groups
A primary outcome event occurred in 137 children receiving balanced fluid, representing 3.4% of the group, compared with 124 children receiving 0.9% saline, or 3.0%.
The difference of 0.4 percentage points was not statistically significant. The risk ratio was 1.10, with a 95% confidence interval of 0.88 to 1.40. Median hospital free days during the 28 days following enrollment were also identical, at 23 days in both treatment groups.
Although balanced fluid in pediatric septic shock did not improve the primary clinical outcome, differences emerged in electrolyte measures. Hyperchloremia occurred in 31.4% of children receiving balanced fluid and 49.0% receiving saline. Hypernatremia was also less frequent with balanced fluid, occurring in 1.8% and 3.1% of participants, respectively.
Conversely, hyperlactatemia occurred in 19.8% of the balanced fluid group and 16.7% of the saline group. No differences were identified in other safety outcomes or adverse events.
The results indicate that either fluid strategy produced comparable major kidney and survival outcomes in children requiring fluid resuscitation for septic shock, despite differences in several laboratory measures.
Reference
Balamuth F et al. Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock. N Engl J Med. 2026;10.1056/NEJMoa2601969.
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