0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis (NCT05808972) | Clinical Trial Compass
CompletedPhase 4
0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis
Tunisia92 participantsStarted 2022-11-01
Plain-language summary
Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- All patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial pH ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/L) and blood glucose ≥ 14 mmol/L and need for ICU.
Exclusion Criteria:
* \< 16 Y
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared regular saline to balanced IV fluids for treating severe diabetic ketoacidosis — can you explain what 'balanced solutions' means and whether current evidence supports using one over the other in my specific situation?
2Since this trial has already completed, has any results data been published yet, and if so, what did it show about which fluid type helped patients reach recovery milestones faster or more safely?
3The trial measured a 'composite endpoint' — can you walk me through what that actually means in practice, like what specific markers of recovery they were tracking, and how that relates to how my DKA would be treated?
4Given that this was a Phase 4 trial, meaning both types of fluids are already approved treatments, is there a current standard of care your team follows for severe DKA, and would the findings from this kind of study change how you'd treat me?
5Are there particular risks or complications — like effects on kidney function or blood chemistry — where the choice between saline and a balanced solution might matter more for someone with my health history?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with composite endpoint achievement