Summary: In a single-centre, double-blind randomised controlled trial of 67 children with type 1 diabetes presenting in diabetic ketoacidosis (DKA), Ringer’s lactate (RL) as the initial fluid shortened the mean time to DKA resolution to 12.9 hours versus 16.8 hours with 0.9% saline (mean difference 3.85 hours, 95% CI 0.3 to 8). RL was also associated with a smaller rise in serum chloride and greater bicarbonate recovery.
PICO Summary
| Element | Detail |
|---|---|
| Population | 67 children aged 9 months to 12 years with type 1 diabetes presenting in DKA; single teaching-hospital paediatric emergency and intensive care setting, India; double-blind RCT. |
| Intervention | Ringer’s lactate as the sole initial fluid for both resuscitation and replacement (n=33). |
| Comparison | 0.9% saline as the sole initial fluid for both resuscitation and replacement (n=34). |
| Outcome | Primary: mean time to DKA resolution 12.9±7.9 h (RL) vs 16.8±9 h (saline); mean difference 3.85 h (95% CI 0.3 to 8); HR for resolution 1.39 (95% CI 1.25 to 1.56). Secondary: rise in chloride from baseline lower with RL at 4 h (3.9±5.1 vs 8.7±5.6 mmol/L) and 8 h (4.4±8.3 vs 10.8±7.7 mmol/L); rise in bicarbonate to 12 h higher with RL (14.7±1.6 vs 12.9±3.1). No mortality or clinical safety endpoint (e.g. cerebral oedema) reported as primary; absolute risk reduction/NNT not applicable to this continuous primary outcome. |
Ringer's lactate vs saline in paediatric DKA
Double-blind RCT · type 1 diabetes · children in DKA
Ringer's lactate resolved DKA about 3.9 hours faster than saline with less hyperchloraemia, but the small single-centre sample was underpowered for cerebral oedema and other patient-centred outcomes.
Expert Commentary
This trial offers a physiologically coherent and methodologically reasonable signal that a balanced crystalloid resolves paediatric DKA somewhat faster than 0.9% saline, and the double-blind design lends it more weight than the open-label comparisons that dominate this literature. The verdict, however, should be read as suggestive rather than definitive. The primary outcome was a process measure (biochemical DKA resolution), and the mean difference of 3.85 hours carried a 95% confidence interval whose lower bound (0.3 hours) sits almost on the line of no benefit, so the precision of the effect is limited. The single weighed limitation worth foregrounding is sample size: 67 children at one centre is too few to detect or exclude differences in the outcomes parents and clinicians care about most, namely cerebral oedema, acute kidney injury and length of stay, none of which were powered endpoints. The chloride and bicarbonate findings are mechanistically reassuring but remain surrogates. Can I use this with my patients? Cautiously yes for a child in uncomplicated DKA where local protocols already permit a balanced crystalloid, but this trial alone does not mandate abandoning saline. I would welcome a larger multicentre trial powered for patient-centred safety outcomes before changing guideline-level practice.
References
Agarwal A, Jayashree M, Nallasamy K, Dayal D, Attri SV. 0.9% Saline versus Ringer’s lactate as initial fluid in children with diabetic ketoacidosis: a double-blind randomized controlled trial. BMJ Open Diabetes Res Care. 2025;13(2):e004623. doi:10.1136/bmjdrc-2024-004623