Fluid Administration in Ketoacidosis (DRINK)

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.

NCT Number	NCT06541535
Lead Sponsor	Centre Hospitalier Universitaire de Nice
Conditions	Diabetic Keto-acidosis
Enrollment	300 participants
Start Date	2025-11-26
Primary Completion	2027-12 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-26