Which fluid works best for severe diabetic ketoacidosis? a new trial aims to find out
NCT ID NCT06541535
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of IV fluids—saline and Ringer lactate—in 300 adults with severe diabetic ketoacidosis (DKA) admitted to the ICU. The goal is to see which fluid helps resolve DKA faster within 24 hours. Current guidelines recommend saline, but it may cause side effects; Ringer lactate has a more balanced composition and might work better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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CHU NICE
RECRUITINGNice, France