Global Collaboration Clarifies Sepsis Care for Children

Research By: Michelle D. Eckerle, MD

Post Date: May 22, 2026 | Publish Date: April 24, 2026

Landmark trial supports flexible fluid choice for treating children with septic shock

For years, clinicians have debated a fundamental question in pediatric emergency care: does the type of IV fluid used in septic shock actually matter?

A new international trial now provides an answer based on real-world care across thousands of children.

The PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis (PRoMPT BOLUS) trial, a large pragmatic randomized study conducted across 47 emergency departments in five countries, compared 0.9% saline with balanced crystalloids (most commonly Lactated Ringer’s solution) in more than 9,000 children treated for suspected septic shock. The findings, published in the New England Journal of Medicine, showed no meaningful difference in outcomes between the two approaches.

“This matters because adult studies have had mixed findings, with some suggesting benefit from balanced fluids in the treatment of septic shock. However, until now we have not have reliable evidence in children to guide care,” says Michelle Eckerle, MD, from the Division of Emergency Medicine who served as site principal investigator for the study.

A question answered through collaboration

PRoMPT BOLUS is one of the largest pediatric sepsis trials ever conducted. The study brings together emergency departments across multiple international research networks, including Pediatric Emergency Care Applied Research Network in the United States, Pediatric Emergency Research Canada, and Paediatric Research in Emergency Departments International Collaborative across Australia and New Zealand.

By embedding the trial directly into routine emergency care, investigators were able to enroll children early in their treatment while allowing clinicians to otherwise manage care as usual. This approach ensured that the findings reflect everyday practice across diverse clinical settings.

What the study found

The primary outcome was major adverse kidney events within 30 days, defined as a composite of death, need for dialysis or persistent kidney dysfunction. This outcome occurred at nearly identical rates: 3.4% in children receiving balanced fluids and 3.0% in those receiving saline.

There were also no meaningful differences in the individual components of the primary outcome. Mortality before hospital discharge was 1.1% in both groups, and 90-day mortality remained low at just over 2%. Kidney-related complications, including the need for dialysis and persistent dysfunction, were similarly rare and comparable.

Measures of recovery were also similar. Children in both groups had a median hospital stay of five days and a median of 23 hospital-free days within the first month. Complications such as blood clots and brain swelling were uncommon and did not differ between groups.

As expected, the fluids produced different laboratory profiles. Children who received saline were more likely to develop higher than normal chloride and sodium levels in the blood, while those receiving balanced fluids—most commonly Lactated Ringer’s in clinical practice—had slightly higher lactate levels. These biochemical differences did not translate into clinically meaningful differences in outcomes.

Subgroup analyses across age, illness severity, and total fluid volume showed consistent results, with no clear advantage of one fluid over the other.

What this means for care today

These findings provide greater confidence in current practice and will support ongoing education and collaboration across clinical settings, including Emergency Medicine, Hospital Medicine, Critical Care, and other disciplines involved in the care of children with sepsis.

“These findings support flexibility in care. Clinicians can choose fluids based on availability, medication compatibility and individual patient needs, and families can be reassured that the fluids commonly used to treat children with septic shock are safe and appropriate,” says Eckerle.

This global effort provides strong evidence to help guide pediatric sepsis care. In children with suspected septic shock, both saline and balanced crystalloids are safe, effective, and appropriate choices.

About the study

Cincinnati Children’s played a meaningful role in this work through its participation in Pediatric Emergency Care Applied Research Network and the Hospitals of the Midwest Emergency Research (HOMERUN) node.

Co‑authors of the study included experts from 48 institutions across the United States (22), Canada (12), Australia (11), New Zealand (2), and Costa Rica (1).

The PRoMPT BOLUS trial (NCT04102371) was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and supported by additional national and international funding organizations.

The study was conducted through established international research networks, including the Pediatric Emergency Care Applied Research Network (PECARN) and the Pediatric Research in Emergency Departments International Collaborative (PREDICT).

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Publication Information

Original title:	Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock
Published in:	New England Journal of Medicine
Publish date:	April 24, 2026

Read the study