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.