PRoMPT BOLUS Trial Results: Balanced Fluids and Normal Saline Have Similar Outcomes in Children with Suspected Septic Shock

As a participating site in the Pediatric Emergency Care Applied Research Network (PECARN), UCSF Benioff Children's Hospital Oakland was part of a landmark international trial that found similar outcomes with balanced crystalloid fluids and 0.9% saline in children receiving fluid resuscitation for suspected septic shock. Results from the multicenter PRoMPT BOLUS trial specifically showed no significant difference in death, major adverse kidney events, or hospital recovery between balanced fluids (e.g., Lactated Ringer's solution and Plasma-Lyte) and 0.9% saline. Results were published in The New England Journal of Medicine in April 2026.

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“Fluid resuscitation is one of the first and most important interventions we provide to children with septic shock, yet questions have remained about which fluids lead to the best outcomes,” said Karim Mansour, MD, site principal investigator and section chief for Pediatric Emergency Medicine at Benioff Children's Hospital Oakland (pictured). “This study provides high-quality evidence that both balanced crystalloids and saline are safe and effective options, helping clinicians make treatment decisions with greater confidence.”

The trial enrolled 9,041 children (age: two months to < 18 years) who were treated for suspected septic shock in emergency departments (EDs) between August 25, 2020, and October 31, 2025. PRoMPT BOLUS was conducted across 47 sites within PECARN in the United States, the Pediatric Emergency Research Canada network in Canada, the Pediatric Research in Emergency Departments International Collaborative in Australia and New Zealand, and an ED in Costa Rica. UCSF Benioff’s Children’s Hospital Oakland was among the participating PECARN sites.

The primary endpoint was a major adverse kidney event, defined as death, new renal replacement therapy, or persistent kidney dysfunction within 30 days of enrollment or hospital discharge — whichever occurred first. Secondary endpoints included length of hospital stay, number of hospital-free days during the 28 days after enrollment, and death from any cause before hospital discharge and within 90 days of randomization.  

The data showed no meaningful difference in the incidence of major adverse kidney events between children who received balanced fluids (3.4%) and those who received 0.9% saline (3.0%). Investigators also found no significant differences in length of stay, hospital-free days, or mortality between the two groups.

Balanced fluids were associated with lower rates of hyperchloremia and hypernatremia than saline. However, “these biochemical effects did not translate to improved patient-centered outcomes,” the researchers wrote.

The findings suggest that both balanced crystalloids and 0.9% saline are safe options for fluid resuscitation in children with suspected septic shock and provide important evidence to inform clinical practice worldwide. 

Reference 

Balamuth F, Weiss SL, Long E, et al. Balanced fluid or 0.9% saline in children treated for septic shock. N Engl J Med. 2026. doi:10.1056/NEJMoa2601969