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Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock
Fran Balamuth1,2,3, Scott L Weiss4,5, Elliot Long6,7,8
1Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia.
Insights
In pediatric septic shock, balanced crystalloid fluid showed no significant difference in major adverse kidney events compared to 0.9% saline. This large trial found similar outcomes for children receiving either fluid resuscitation, impacting pediatric critical care guidelines.
Area of Science:
- Pediatric critical care medicine
- Nephrology
- Emergency medicine
Background:
- Septic shock in children requires prompt fluid resuscitation.
- The optimal fluid choice (balanced crystalloids vs. 0.9% saline) remains debated.
- Previous studies have yielded conflicting results regarding fluid efficacy and safety in pediatric septic shock.
Purpose of the Study:
- To compare the effectiveness of balanced crystalloid fluid versus 0.9% saline for fluid resuscitation in children with septic shock.
- To determine if balanced fluids reduce major adverse kidney events compared to saline.
- To assess safety outcomes and hospital-free days associated with different fluid choices.
Main Methods:
- Pragmatic clinical trial involving 9041 children (2 months to <18 years) with suspected septic shock.
- Randomized assignment to receive either balanced fluid or 0.9% saline for up to 48 hours.
- Primary outcome: major adverse kidney event (death, renal-replacement therapy, or persistent kidney dysfunction) at 30 days.
Main Results:
- No significant difference in major adverse kidney events between balanced fluid (3.4%) and 0.9% saline (3.0%) groups (P=0.85).
- Similar median hospital-free days (23) in both groups.
- Balanced fluid group had lower incidence of hyperchloremia (31.4% vs. 49.0%) but higher hyperlactatemia (19.8% vs. 16.7%) than the saline group.
Conclusions:
- Balanced crystalloid fluid and 0.9% saline demonstrate comparable efficacy in preventing major adverse kidney events in pediatric septic shock.
- Fluid choice did not significantly impact mortality, need for renal-replacement therapy, or persistent kidney dysfunction.
- While balanced fluids reduced hyperchloremia, overall safety profiles were similar, suggesting current practice can continue with either fluid type.
Background:
Whether treatment with balanced crystalloid fluid leads to better outcomes than 0.9% saline in children treated for septic shock is debated.
Methods:
In this pragmatic clinical trial conducted at 47 emergency departments in five countries, patients (2 months to <18 years of age) with suspected septic shock and abnormal perfusion were randomly assigned to receive fluid resuscitation with either balanced fluid or 0.9% saline for up to 48 hours. The primary outcome was a major adverse kidney event (a composite of death, new renal-replacement therapy, or persistent kidney dysfunction) at 30 days after enrollment or hospital discharge, whichever occurred first.
Results:
Of 9041 enrolled patients, 277 (6.1%) in the balanced-fluid group and 282 (6.2%) in the 0.9%-saline group withdrew from the trial, leaving 4235 and 4247 patients, respectively, for analysis. A primary-outcome event occurred in 137 patients (3.4%) in the balanced-fluid group and in 124 (3.0%) in the 0.9%-saline group (difference, 0.4 percentage points; 95% confidence interval [CI], -0.5 to 1.3; risk ratio, 1.10; 95% CI, 0.88 to 1.40; P = 0.85). The median number of hospital-free days during 28 days after enrollment was 23 (interquartile range, 19 to 25) in both groups. Hyperchloremia occurred in 868 patients (31.4%) in the balanced-fluid group and in 1383 (49.0%) in the 0.9%-saline group; hypernatremia in 52 (1.8%) and 89 (3.1%), respectively; and hyperlactatemia in 260 (19.8%) and 228 (16.7%). No differences in other safety outcomes or adverse events were seen.
Conclusions:
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. (Funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; PRoMPT BOLUS ClinicalTrials.gov number, NCT04102371.).
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