Fluid Administration in Ketoacidosis (DRINK)

Recruiting now · Phase 4

Conditions studied: Diabetic Keto-acidosis

In brief

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.

Key facts

Study ID

NCT06541535

Run by

Centre Hospitalier Universitaire de Nice

People needed

300

Starts

2025-11-26

Expected to finish

2028-07-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients <18 years
• Pregnant women
• Patients under protection
• Patients with a decision to withdraw life-sustaining therapy
• Contraindication to isotonic saline or Ringer Lactate
• Non-affiliation to social security

Where it is running

• CHU NICE — Nice, France (enrolling)

Full record on ClinicalTrials.gov

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