The balanced-versus-saline argument has run for a decade on the strength of laboratory findings and adult trials with narrow margins. PRoMPT BOLUS settled the paediatric version. 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 groups.
The biochemistry did what everyone expected. 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 went the other way, 19.8% versus 16.7%. None of it changed an outcome that mattered.
That gap between biochemistry and outcome is the finding. A laboratory abnormality that reliably follows an intervention is not the same as harm from it, and a decade of argument about chloride load has now been tested at scale in children and found not to move death or dialysis. For a clinician in a setting where balanced solutions are expensive or intermittently stocked — which describes much of India — this is permission to use what is available and stop worrying about it.
- Use whichever crystalloid is available for paediatric septic shock; neither is better on death or kidney outcomes
- Expect hyperchloraemia with saline in about half of children — recognise it, and do not treat it as a reason to change fluid
- Spend the attention on what does matter: recognition speed, antibiotic timing, and reassessment after each bolus
- Note the population — suspected septic shock with abnormal perfusion, not undifferentiated dehydration
- Do not read this as settling the adult ICU question, which rests on separate trials
The statistics, in plain English
A risk ratio of 1.10 with a confidence interval of 0.88 to 1.40 sits squarely across 1.0, and with over 9,000 children randomised this is a well-powered null rather than an uncertain one. Read the absolute numbers instead of the ratio: 3.4% versus 3.0%, a difference of 0.4 percentage points with an interval from -0.5 to 1.3. Even the least favourable end of that interval is a difference of about one child in a hundred. The hyperchloraemia gap, by contrast, is enormous and entirely real — which is exactly why intermediate laboratory endpoints are unreliable stand-ins for outcomes.
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