NCT06541535 Fluid Administration in Ketoacidosis (DRINK)
| NCT ID | NCT06541535 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Diabetic Keto-acidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-11-26 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Keto-acidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06541535 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06541535 currently recruiting?
Yes, NCT06541535 is actively recruiting participants. Contact the research team at jozwiak.m@chu-nice.fr for enrollment information.
Where is the NCT06541535 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT06541535 clinical trial?
NCT06541535 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 300 participants.