Back
Science

Large Clinical Trial Finds No Difference in Outcomes Between Balanced Fluids and Saline for Pediatric Septic Shock

Generated on: Last updated: 1 sources
View source

"This largest-ever clinical trial for children treated for septic shock has immediate clinical application..." – Rohan Hazra, M.D., NIH

Landmark NIH Trial Finds No Outcome Difference Between Balanced Fluids and Saline for Pediatric Septic Shock

A major clinical trial supported by the National Institutes of Health (NIH) has found that for children treated for septic shock, there is no meaningful difference in patient outcomes between balanced crystalloid fluids and standard 0.9% saline. The study, which is the largest ever conducted on this question, enrolled over 9,000 participants across five countries.

Key Findings

The research compared balanced crystalloid fluid—designed to mimic human plasma—against 0.9% saline.

  • No difference in critical outcomes: Over 4,200 children aged 2 months to 17 years were assigned to each treatment group. The study found no significant differences between the groups for death, persistent kidney dysfunction, or the need for new renal-replacement therapy.
  • Equal recovery time: Both groups achieved a median of 23 hospital-free days during the 28 days following enrollment.
  • Biochemical differences without clinical impact: Children receiving 0.9% saline showed higher rates of abnormally high chloride and sodium levels, while the balanced fluid group had slightly higher lactate levels. These biochemical differences did not translate into any meaningful differences in patient outcomes.

Expert Commentary

Rohan Hazra, M.D., acting director of NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development, stated that the study allows physicians to "confidently choose either intervention as a standard of care" for these vulnerable patients.

Limitations

While the results are robust, the authors note important limitations:

  • Generalizability: The study targeted children with community-acquired sepsis in emergency departments located in high-resource settings. Results may not generalize to low-resource settings or cases of hospital-acquired sepsis.
  • Clinical judgment bias: Treatment was initiated based on clinical observations, not lab results. The authors cannot exclude the possibility that physicians may have had a preference for one fluid type in the sickest children or those requiring very high fluid volumes.

Funding and Leadership

The trial was supported by NIH grants R01HD101528 and P50DK114786. It was led by the Pediatric Emergency Care Applied Research Network (PECARN), funded through HRSA's EMSC program, in collaboration with institutions in Canada, Australia, New Zealand, and Costa Rica.