April 26, 2026
3 min read
Key takeaways:
- A study of more than 8,000 children compared saline vs. balanced fluid for septic shock resuscitation.
- The study found no difference in the rate of major adverse kidney outcomes between the two options.
BOSTON — A study of more than 8,000 children in five countries with suspected septic shock showed no difference in kidney complications when they received balanced fluid vs. 0.9% saline for resuscitation.
The results were published April 24 in The New England Journal of Medicine and presented the next day here at the Pediatric Academic Societies annual meeting.
“Saline has the advantage of a long record — 150 years of use,” Scott L. Weiss, MD, MSCE, FCCM, chief of critical care medicine and vice chair of research in the department of pediatrics at Nemours Children’s Hospital, told Healio in an interview. “It’s inexpensive, it’s compatible with pretty much all other medications, which makes it a practical choice when you are giving multiple things to a patient in short periods of time through similar IVs, and it is isotonic to the blood, so you don’t have to worry about concerns about swelling of the brain.”
However, Weiss said there are concerns that high volumes of saline could increase chloride levels in the blood and lead to kidney complications in children. Two studies from Vanderbilt University Medical Center showed that using balanced fluid instead of saline could reduce complications, although Weiss said those results have not been replicated since.
Some physicians have switched to using balanced fluid to resuscitate children with septic shock, but when Weiss and colleagues surveyed emergency physicians, they found that the vast majority still use saline.
“The story changes a little bit when you move patients to the ICU,” Frances Balamuth, MD, PhD, MSCE, professor of pediatrics at Perelman School of Medicine at the University of Pennsylvania, told Healio. “In our survey of ICU folks, it was a much more balanced answer.”
Balamuth, Weiss and colleagues developed the PRoMPT BOLUS trial to study if switching to balanced fluid at a large scale would reduce kidney complications. They conducted the pragmatic clinical trial at 47 EDs in Australia, Canada, Costa Rica, New Zealand and the United States from Aug. 26, 2020, through Oct. 31, 2025. It included 8,482 children aged 2 months through 17 years (50.8% boys; median age, 6.8 years) who presented to the ED with suspected septic shock.
The researchers assigned 4,235 children to receive balanced fluid and 4,247 children to receive 0.9% saline. Each child needed to receive at least two boluses of fluid to be included. The primary outcome was a major adverse kidney event — including renal replacement therapy, persistent kidney dysfunction and death — within 30 days of treatment.
Balamuth said the researchers hypothesized that use of balanced fluid would result in fewer kidney complications compared with saline. The results showed no difference.
According to the authors, major adverse kidney events occurred in 3.4% of children who received balanced fluid and 3% of children who received saline (risk ratio = 1.1; 95% CI, 0.88-1.4). The researchers also found no difference in secondary outcomes, including length of hospitalization, hospital-free days following treatment, death before discharge or death within 90 days of treatment.
When looking at safety outcomes, the authors found that children who received balanced fluid were less likely to develop hypernatremia and hyperchloremia than children who received saline, and they were more likely to develop hyperlactatemia.
“I think we were reassured — or gained confidence — by the fact that we saw all of the biochemical differences that were expected,” Balamuth said. “But those didn’t translate to clinical changes.”
Weiss said this work is ongoing. The researchers collected blood and urine samples at three sites to see if there are any subtle differences in kidney injury biomarkers. They are also conducting two ancillary studies — one that is using electronic health record data to track long-term outcomes and another investigating endothelial and glycocalyx biomarkers to better understand the mechanistic effects of each fluid.
“Our findings are very clear that any fluid you have on hand is safe and effective to use, and most kids will do great with that,” Balamuth said.
For more information:
Frances Balamuth, MD, PhD, MSCE, can be reached at balamuthf@chop.edu.
Scott Weiss, MD, MSCE, FCCM, can be reached at scott.weiss@nemours.org.
Sources/Disclosures
Source:
Balamuth F, et al. New Engl J Med. 2026; doi:10.1056/NEJMoa2601969.
References:
- Balamuth F. Release of the PRoMPT BOLUS Results. Presented at: Pediatric Academic Societies annual meeting; April 24-27, 2026; Boston.
- Weiss SL. Controversies in the choice of fluid for septic shock. Presented at: Pediatric Academic Societies annual meeting; April 24-27, 2026; Boston.
Disclosures:
Balamuth reports no relevant financial disclosures. Weiss reports receiving travel funding from Fisher Scientific. Please see the study for all other authors’ relevant financial disclosures.
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