Fluid Administration in Ketoacidosis (DRINK)

Centre Hospitalier Universitaire de Nice

Status and phase: Not yet enrolling; Phase 4

Conditions: Diabetic Keto-acidosis

Treatments: Drug: Fluid resuscitation with isotonic saline only; Drug: Fluid resuscitation with Ringer Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT06541535

22-API-03

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Isotonic saline

Active Comparator group

Treatment:

Drug: Fluid resuscitation with isotonic saline only

Ringer Lactate

Experimental group

Treatment:

Drug: Fluid resuscitation with Ringer Lactate