Balanced Fluids vs Saline Show No Difference in Pediatric Septic Shock Outcomes
A landmark 9,000-patient trial finds balanced crystalloids and normal saline perform equally for children in septic shock.
Summary
A large international clinical trial involving over 9,000 children with septic shock found no meaningful difference in outcomes between balanced crystalloid fluids and standard 0.9% saline. The primary outcome — a composite of death, need for kidney replacement therapy, or persistent kidney dysfunction at 30 days — occurred in roughly 3% of patients in both groups. While saline caused significantly more hyperchloremia and hypernatremia, balanced fluids led to slightly more hyperlactatemia. Hospital-free days were identical between groups. These findings challenge assumptions carried over from adult sepsis trials suggesting balanced fluids are superior, and suggest clinicians may safely use either fluid type in pediatric emergency resuscitation without compromising kidney outcomes.
Detailed Summary
For years, clinicians have debated whether balanced crystalloid solutions — such as lactated Ringer's or PlasmaLyte — offer meaningful advantages over standard 0.9% normal saline when resuscitating critically ill patients. Adult trials like SMART and SALT-ED suggested balanced fluids reduce major adverse kidney events, but whether these findings translate to children has remained unclear — until now.
The PRoMPT BOLUS trial enrolled 9,041 children aged 2 months to under 18 years presenting with suspected septic shock and abnormal perfusion across 47 emergency departments in five countries. Patients were randomly assigned to receive either balanced fluid or 0.9% saline for up to 48 hours. The primary endpoint was a composite of death, new renal-replacement therapy, or persistent kidney dysfunction at 30 days.
The results were striking in their equivalence. Major adverse kidney events occurred in 3.4% of the balanced-fluid group versus 3.0% in the saline group — a non-significant difference. Median hospital-free days at 28 days were identical at 23 in both groups. Hyperchloremia was substantially more common with saline (49.0% vs 31.4%), and hypernatremia was also higher in the saline group, but these electrolyte differences did not translate into detectable clinical harm by the measured outcomes.
For clinicians, these findings are practically important: neither fluid type appears superior for preventing kidney injury or death in pediatric septic shock. The choice of resuscitation fluid in children may safely be guided by availability, cost, and institutional preference rather than a mandate to use balanced solutions.
Several caveats apply. This summary is based on the abstract only, so granular subgroup analyses and secondary outcomes are not fully assessable. The pragmatic design allowed variation in clinical care beyond fluid type. Additionally, the relatively low event rate (approximately 3%) may limit power to detect smaller but clinically meaningful differences.
Key Findings
- No significant difference in death, renal-replacement therapy, or kidney dysfunction between balanced fluids and saline (3.4% vs 3.0%).
- Hospital-free days at 28 days were identical (median 23 days) in both treatment groups.
- Saline caused significantly more hyperchloremia (49% vs 31%) and hypernatremia (3.1% vs 1.8%).
- Balanced fluid was associated with slightly more hyperlactatemia (19.8% vs 16.7%).
- Findings suggest fluid choice in pediatric septic shock can be guided by availability and cost, not assumed superiority.
Methodology
Pragmatic randomized controlled trial across 47 emergency departments in five countries (USA, Canada, Australia, New Zealand, Costa Rica), enrolling 9,041 children aged 2 months to under 18 years with suspected septic shock. Patients received assigned fluid for up to 48 hours; primary outcome was a 30-day composite of death, new renal-replacement therapy, or persistent kidney dysfunction.
Study Limitations
This summary is based on the abstract only, as the full text is not open access; secondary outcomes and subgroup analyses cannot be fully evaluated. The pragmatic design introduced variability in co-interventions beyond fluid type. The low overall event rate (~3%) may limit statistical power to detect smaller but clinically relevant differences between groups.
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