0.9% sodium chloride versus ringer's lactate in the management of severe diabetic ketoacidosis: A randomized trial.

Objective: We aimed to compare the effect of 0.9% sodium chloride (SC) versus ringer's lactate (RL) in the resolution of diabetic ketoacidosis (DKA).

Design: Open randomized trial.

Setting: A medical ICU from November 2022 to September 2023.

Patients: All patients older than 16 years admitted to the ICU for severe DKA.

Intervention: The enrolled patient was assigned to receive RL or 0.9% SC according to the randomization scheme. Insulin therapy protocol was conducted similarly for all patients.

Main variables of interest: Resolution of DKA at H48 defined by a composite endpoint (glycemia < 11 mmol/l, bicarbonates > 15 mmol/l or pH > 7.30 and anion gap < 16), change in base excess, insulin needs, fluid administration volume, electrolytes (sodium, potassium, chloride), ICU length of stay, and 28-day mortality.

Results: 88 patients were included: SC arm (n = 42) versus RL arm (n = 46). No significant differences were observed in diabetic ketoacidosis resolution, other variables of interest or in the subgroup analysis. The monitored biomarkers showed in the RL group: a better improvement of bicarbonate at H12 (p = 0.05), best potassium level both at H24 (p = 0.008) and H48 (0.041), lower chloride at H48 (p = 0.002) and higher glycemia at H24.

Conclusion: RL did not lead to faster resolution of diabetic ketoacidosis but decreased the risk of hyperchloremia and hypokalemia without increasingthe chance of hyperlactatemia.

Clinical trial registration number: NCT05808972.