Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock.
Summary
Online ahead of print. Original Article 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
Content
# Online ahead of print.
*Original Article*
# 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.).
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DOI: 10.1056/NEJMoa2601969