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Fluid Administration in Ketoacidosis (DRINK)

RecruitingPhase 4Ages 18 Years - anyAllCentre Hospitalier Universitaire de Nice
NCT06541535 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 randomiz

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📋 Eligibility rules (as published)
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
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What it tests

  • Fluid resuscitation with isotonic saline only
  • Fluid resuscitation with Ringer Lactate
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Where

1 site
CHU NICE
Nice, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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