2026-04-24 アメリカ国立衛生研究所（NIH）
＜関連情報＞
- https://www.nih.gov/news-events/news-releases/clinical-trial-finds-no-difference-fluid-treatment-options-pediatric-sepsis
- https://www.nejm.org/doi/full/10.1056/NEJMoa2601969
敗血症性ショックの治療を受けた小児におけるバランス輸液または0.9%生理食塩水 Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock
Fran Balamuth, M.D., Ph.D., Scott L. Weiss, M.D., Elliot Long, B.M., B.S., Ph.D., Graham C. Thompson, M.D., Amanda S. Artis, M.S., M.P.H., Atzael B. Campos, M.S., Meredith L. Borland, M.B., B.S., +55 , for the PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks
The New England Journal of Medicine Published: April 23, 2026
DOI: 10.1056/NEJMoa2601969
Abstract
Background
Whether treatment with balanced crystalloid fluid leads to better outcomes than 0.9% saline in children treated for septic shock is debated.
Methods
In this pragmatic clinical trial conducted at 47 emergency departments in five countries, patients (2 months to <18 years of age) with suspected septic shock and abnormal perfusion were randomly assigned to receive fluid resuscitation with either balanced fluid or 0.9% saline for up to 48 hours. The primary outcome was a major adverse kidney event (a composite of death, new renal-replacement therapy, or persistent kidney dysfunction) at 30 days after enrollment or hospital discharge, whichever occurred first.
Results
Of 9041 enrolled patients, 277 (6.1%) in the balanced-fluid group and 282 (6.2%) in the 0.9%-saline group withdrew from the trial, leaving 4235 and 4247 patients, respectively, for analysis. A primary-outcome event occurred in 137 patients (3.4%) in the balanced-fluid group and in 124 (3.0%) in the 0.9%-saline group (difference, 0.4 percentage points; 95% confidence interval [CI], −0.5 to 1.3; risk ratio, 1.10; 95% CI, 0.88 to 1.40; P=0.85). The median number of hospital-free days during 28 days after enrollment was 23 (interquartile range, 19 to 25) in both groups. Hyperchloremia occurred in 868 patients (31.4%) in the balanced-fluid group and in 1383 (49.0%) in the 0.9%-saline group; hypernatremia in 52 (1.8%) and 89 (3.1%), respectively; and hyperlactatemia in 260 (19.8%) and 228 (16.7%). No differences in other safety outcomes or adverse events were seen.
Conclusions
Among children treated for septic shock, no significant difference was seen in the incidence of death, new renal-replacement therapy, or persistent kidney dysfunction when fluid resuscitation was administered with balanced fluid as compared with 0.9% saline. (Funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; PRoMPT BOLUS ClinicalTrials.gov number, NCT04102371.)
