Clinical trial NCT06541535: Fluid Administration in Ketoacidosis (DRINK)
Official title: Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetic Keto-acidosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Resolution of diabetic ketoacidosis
timeFrame: at 24 hours
Secondary outcomes:
measure: Speed of resolution of metabolic disorders
timeFrame: at 48 hours
measure: Time of resolution of metabolic disorders
timeFrame: at 48 hours
measure: Assess the metabolic tolerance of Ringer Lactate compared to isotonic saline solution
timeFrame: through the end of study average 24 months
measure: Assess the impact of Ringer lactate compared with isotonic saline on renal, neurological and cardiac complications
timeFrame: at 28 days
measure: Assess the impact of Ringer lactate compared with isotonic saline on cardiac complications
timeFrame: at 28 days
measure: Assess the impact of Ringer lactate compared with isotonic saline on renal complications
timeFrame: at 28 days
measure: Assess the impact of Ringer lactate compared with isotonic saline on neurological complications
timeFrame: at 28 days
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
Study officials:
References: