Status:
NOT_YET_RECRUITING
Fluid Administration in Ketoacidosis (DRINK)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Diabetic Keto-acidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 sali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06541535
Start Date
December 1 2024
End Date
July 1 2027
Last Update
August 7 2024
Active Locations (1)
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1
CHU NICE
Nice, France