Objective: To determine if Ringer's lactate is superior to 0.9% sodium chloride solution for resolution of acidosis in the management of diabetic ketoacidosis (DKA).
Design: Parallel double blind randomized controlled trial.
Methods: Patients presenting with DKA at Kalafong and Steve Biko Academic hospitals were recruited for inclusion in this study if they were >18 years of age, had a venous pH >6.9 and ≤7.2, a blood glucose of >13 mmol/l and had urine ketones of ≥2+. All patients had to be alert enough to give informed consent and should have received <1 l of resuscitation fluid prior to enrolment.
Results: Fifty-seven patients were randomly allocated, 29 were allocated to receive 0.9% sodium chloride solution and 28 to receive Ringer's lactate (of which 27 were included in the analysis in each group). An adjusted Cox proportional hazards analysis was done to compare the time to normalization of pH between the 0.9% sodium chloride solution and Ringer's lactate groups. The hazard ratio (Ringer's compared with 0.9% sodium chloride solution) for time to venous pH normalization (pH = 7.32) was 1.863 (95% CI 0.937-3.705, P = 0.076). The median time to reach a pH of 7.32 for the 0.9% sodium chloride solution group was 683 min (95% CI 378-988) (IQR: 435-1095 min) and for Ringer's lactate solution 540 min (95% CI 184-896, P = 0.251). The unadjusted time to lower blood glucose to 14 mmol/l was significantly longer in the Ringer's lactate solution group (410 min, IQR: 240-540) than the 0.9% sodium chloride solution group (300 min, IQR: 235-420, P = 0.044). No difference could be demonstrated between the Ringer's lactate and 0.9% sodium chloride solution groups in the time to resolution of DKA (based on the ADA criteria) (unadjusted: P = 0.934, adjusted: P = 0.758)
Conclusion: This study failed to indicate benefit from using Ringer's lactate solution compared to 0.9% sodium chloride solution regarding time to normalization of pH in patients with DKA. The time to reach a blood glucose level of 14 mmol/l took significantly longer with the Ringer's lactate solution.