The balanced-versus-saline argument has been running on chloride biochemistry and adult trials with narrow margins. PRoMPT BOLUS answered the paediatric version at a scale that settles it. This pragmatic trial across 47 emergency departments in five countries randomised 9,041 children aged 2 months to under 18 years with suspected septic shock and abnormal perfusion to balanced crystalloid or 0.9% saline for up to 48 hours.
The primary outcome — a major adverse kidney event, meaning death, new renal replacement therapy or persistent kidney dysfunction by 30 days or discharge — occurred in 137 children (3.4%) on balanced fluid and 124 (3.0%) on saline. The difference was 0.4 percentage points (95% CI -0.5 to 1.3), risk ratio 1.10 (95% CI 0.88 to 1.40, p=0.85). Median hospital-free days were 23 in both arms.
The biochemistry behaved exactly as predicted and meant nothing. Hyperchloraemia occurred in 49.0% of the saline group versus 31.4% of the balanced group, and hypernatraemia in 3.1% versus 1.8%. Hyperlactataemia ran the other way, 19.8% versus 16.7%. None of it moved death or dialysis.
That disconnect is the transferable lesson. A laboratory abnormality that reliably follows an intervention is not the same as harm from it, and a decade of chloride argument has now been tested at scale and found not to matter for outcomes that do.
Practically, in departments where balanced solutions are expensive, intermittently stocked or simply not on the resuscitation trolley — which describes a great many Indian emergency departments — this is explicit permission to use what is available. The attention belongs on recognition speed, antibiotic timing and reassessment after each bolus.
- Use whichever crystalloid is immediately available for paediatric septic shock; neither improved death or kidney outcomes
- Expect hyperchloraemia in about half of children given saline and do not treat it as a reason to switch
- Reassess perfusion after every bolus rather than working through a fixed volume
- Note the population: suspected septic shock with abnormal perfusion, not undifferentiated dehydration
- This does not settle the adult intensive care question, which rests on separate trials
The statistics, in plain English
With over 9,000 children randomised, a risk ratio of 1.10 spanning 0.88 to 1.40 is a well-powered null rather than an uncertain result. The absolute figures matter more than the ratio here: 3.4% versus 3.0%, difference 0.4 percentage points with an interval from -0.5 to 1.3. Even the least favourable end of that interval is about one extra event per hundred children. Contrast that with the hyperchloraemia difference, which is enormous, entirely real, and completely disconnected from outcome — the clearest recent demonstration of why intermediate laboratory endpoints are unreliable stand-ins for what happens to patients.
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