Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06541535 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Fluid Administration in Ketoacidosis (DRINK)

Study acronym: DRINK
StatusRecruiting
PhasePhase 4
Started2025-11-26
View on ClinicalTrials.gov ↗

Amendment history

2026-05-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12→2027-12
Completion date2027-07→2028-07
Start dateestimated 2024-12→confirmed 2025-11-26
Study sitesdetails revised at 1 of 1 site
2024-08-02
minor
Original filing
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.
Trial Details
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