drugset / Trial / NCT06541535

Fluid Administration in Ketoacidosis (DRINK)

NCT06541535

Phase 4 Recruiting 300 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2025-11-26
Primary completion
2027-12
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ringer lactate Other / unclassified 500 ml
Subject Ringer lactate Other / unclassified 1000 ml
Comparator sodium chloride Unknown 500 ml
Comparator sodium chloride Unknown 1000 ml

Indications