Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.
Summary
In a 47-ED multinational pragmatic RCT of pediatric septic shock, balanced crystalloids did not reduce MAKE30 compared with 0.9% saline, and hospital-free days were identical. Balanced fluids lowered hyperchloremia and hypernatremia but had slightly higher hyperlactatemia; safety outcomes were otherwise similar.
Key Findings
- MAKE30 occurred in 3.4% (balanced) vs 3.0% (saline); risk ratio 1.10 (95% CI, 0.88–1.40; P=0.85).
- Hospital-free days (28-day window) were median 23 in both groups.
- Hyperchloremia: 31.4% (balanced) vs 49.0% (saline); hypernatremia: 1.8% vs 3.1%; hyperlactatemia: 19.8% vs 16.7%.
Clinical Implications
Either balanced crystalloids or 0.9% saline are reasonable for initial pediatric septic shock resuscitation with no difference in MAKE30; balanced fluids may be preferred when hyperchloremia/hypernatremia are concerns, while monitoring for lactate changes.
Why It Matters
Sets high-quality evidence for pediatric septic shock fluid choice, showing no renal composite benefit with balanced fluids while clarifying electrolyte profiles.
Limitations
- Pragmatic design may introduce variability in co-interventions and fluid dosing
- Low event rate may limit power to detect small differences; not blinded to fluid type
Future Directions
Explore patient subgroups (e.g., severe hyperchloremia risk, renal vulnerability) and longer-term outcomes; assess cost-effectiveness and protocolized fluid strategies.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Multinational randomized controlled trial with predefined primary endpoint
- Study Design
- OTHER