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 range16 Years

SexALL

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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

What they're measuring

Number of participants with composite endpoint achievement

Timeframe: 48 hours from inclusion

Trial details

NCT IDNCT05808972

SponsorTunis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

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