A large-scale clinical trial has found no significant difference in clinical outcomes for children with sepsis treated with balanced crystalloids versus saline. The PRISM trial, published in the New England Journal of Medicine, observed that the choice of intravenous fluid resuscitation did not alter 30-day mortality or the incidence of new complications in pediatric patients.
Clinical Findings in Pediatric Sepsis Resuscitation
The Pediatric Resuscitation in Sepsis Evaluation (PRISM) trial was conducted to determine if the composition of intravenous fluids—specifically balanced crystalloids like Plasma-Lyte or Lactated Ringer’s versus 0.9% saline—affected patient recovery. Researchers enrolled 1,503 children across 47 pediatric intensive care units.
According to the study results, 30-day mortality rates were 4.0% in the balanced crystalloid group and 4.2% in the saline group. The study authors concluded that these results did not show a statistical advantage for either fluid type. This finding is notable because, in adult populations, some evidence has suggested that balanced crystalloids might reduce the risk of major adverse kidney events, leading to a shift in clinical practice toward balanced solutions.
Why Fluid Choice Remains a Subject of Debate
The debate over fluid resuscitation centers on the potential for saline to induce hyperchloremic metabolic acidosis. Because 0.9% saline contains a higher concentration of chloride than human plasma, critics have long argued that large volumes could cause kidney injury or electrolyte imbalances.
However, the PRISM trial data suggests that in the pediatric population, the physiological impact of these fluids does not translate into measurable differences in clinical outcomes like mortality or organ dysfunction. The Society of Critical Care Medicine and other professional bodies continue to emphasize that for pediatric sepsis, the speed of fluid administration and the recognition of shock remain more critical than the specific type of crystalloid used.
Understanding the Study Parameters
The trial’s design focused on children admitted to the ICU with sepsis who required fluid boluses. Key components of the study included:
- Study Population: 1,503 children aged 45 weeks to 19 years.
- Intervention: Use of balanced crystalloids versus 0.9% saline for all fluid boluses and maintenance fluids during the ICU stay.
- Primary Outcome: Mortality within 30 days of randomization.
- Secondary Outcomes: Incidence of new or progressive multiple organ dysfunction syndrome.
Clinical Implications for Pediatric Care
For clinicians, these findings provide evidence that the choice between balanced crystalloids and saline can be guided by institutional protocol, cost, or availability without compromising patient safety. While the study does not rule out potential benefits in specific, high-risk subgroups, it confirms that in the general pediatric sepsis population, neither fluid type is superior in preventing mortality.
The results reinforce the importance of established sepsis bundles—early recognition, timely antibiotics, and appropriate hemodynamic support—as the primary drivers of survival in pediatric critical care. Future research may continue to examine whether specific subsets of patients, such as those with pre-existing renal conditions, might experience different outcomes, but current data supports the use of either fluid as a safe standard of care.