Note: Single-source report; awaiting corroboration.
A large clinical trial supported by the National Institutes of Health (NIH) compared two types of intravenous crystalloid fluids for treating children with septic shock and found no significant differences in major clinical outcomes. The study included over 9,000 participants aged 2 months to 17 years across five countries, making it the largest trial of its kind.
Researchers assigned approximately 4,200 children to receive either balanced crystalloid fluid, designed to resemble human plasma electrolyte levels, or 0.9% saline solution. The groups showed no significant differences in mortality rates, persistent kidney dysfunction, or need for new renal-replacement therapy. Both groups experienced a median of 23 hospital-free days within 28 days after enrollment.
Biochemical analyses revealed expected differences: children receiving saline had higher blood chloride and sodium levels, while those receiving balanced fluid had elevated lactate levels. However, these variations did not result in differences in patient safety or key clinical outcomes.
The findings suggest clinicians can choose either fluid type as standard care for pediatric septic shock, according to the study’s funding institute. The trial’s large sample size allowed detection of small differences, though researchers noted some limitations in broadly applying the results.
"This largest-ever clinical trial for children treated for septic shock has immediate clinical application," said Rohan Hazra, M.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the research.