Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial
Management of severe diabetic ketoacidosis is based on insulin therapy, correction of metabolic disorders and fluid resuscitation. Current recommendations recommend the first-line use of isotonic saline, whose composition is unbalanced, rich in chloride and sodium compared with plasma. Administration of large volumes of isotonic saline is associated with a risk of hyperchloremic metabolic acidosis and acute renal failure. Balanced solutions (e.g. Ringer Lactate) are solutions with a more balanced electrolyte composition close to that of plasma. They could therefore enable diabetic ketoacidosis to be resolved more quickly than isotonic saline, due to a lower risk of hyperchloremic acidosis. Preliminary data suggest a potential benefit of balanced solutions for fluid resuscitation of patients with severe diabetic ketoacidosis in terms of resolution of diabetic ketoacidosis, but no randomized controlled double-blind study to date has compared balanced solution vs. isotonic saline in this context.
• Admission to emergency department or direct admission to ICU
• Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:
• Blood or capillary glucose \> 11 mmol/L
• Ketonemia or ketonuria \> 0
• Venous or arterial pH \< 7.30 or venous or arterial bicarbonate \< 15 mmol/L
• Volume of fluid administered before inclusion \<1L