Fluid choice in severe diabetic ketoacidosis: balanced fluids vs saline
Official title: Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial
Run by Centre Hospitalier Universitaire de Nice · NCT06541535 · Data updated 2026-11-12
This trial tests whether balanced IV fluids (Ringer Lactate) help resolve severe diabetic ketoacidosis faster than standard isotonic saline in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Status | Recruiting |
| Started | November 26, 2025 |
| Main results expected | December 2027 |
| Study ends | July 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06541535 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe diabetic ketoacidosis admitted to ER or ICU who have not received more than 1 liter of fluids and meet predefined lab criteria.
✕Probably not a fit
Patients who do not respond differently to balanced fluids or who have contraindications to Ringer Lactate may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two fluid strategies for resuscitation in adults with severe diabetic ketoacidosis. Participants are allocated to receive either isotonic saline or balanced Ringer Lactate as their initial fluid therapy. The study focuses on patients admitted from the emergency department or ICU who meet criteria for severe DKA and have not yet received more than 1 liter of fluids. Outcomes of interest include resolution of ketoacidosis, acid-base balance, and renal status, with safety monitoring for potential adverse events. The trial aims to determine if a more balanced electrolyte solution can improve recovery compared with the conventional saline approach.
Why it matters
Potential benefit: If successful, balanced fluids could shorten DKA resolution time and reduce complications related to electrolyte imbalance.
How similar studies have gone: Preliminary data suggest potential benefits of balanced solutions, but no prior randomized double-blind trials have compared them to isotonic saline in this setting.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Chu Nice
Nice, France Recruiting
Study contacts
- Study coordinator: Mathieu JOZWIAK, MD PhD
- Email: jozwiak.m@chu-nice.fr
- Phone: +33492035510
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.