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.).
| Discipline Area | Score |
|---|---|
| Pediatric Emergency Medicine |  |
| Emergency Medicine |  |
This randomized trial compared balanced crystalloid fluid (BCF) vs. 0.9% saline for 8482 children treated for septic shock in 47 EDs in 5 countries. Clinicians and patients were not blinded, but the senior biostatistician and investigators were. A power calculation yielded an enrollment target of 9178. There was no statistically significant difference in the primary outcome, a major adverse kidney event at 30 days after enrollment or hospital discharge, nor in any of the composite components or safety measures. The BCG group had more hypernatremia, hyperchloremia, and hyperlactemia. Since there were no differences between the 2 groups in any patient-important outcomes, you could argue that the trial has no value. However, clinicians and health systems need to balance the difference in cost of the fluids versus the cost of dealing with the laboratory abnormalities.
There is a lot of controversy about fluid selection for resuscitation. This study sheds light on the debate.