Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT05443802
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 18 years or above
* Admission in Intense/Intermediate Care Unit
* Severe DKA due to all types of diabetes (T1D, T2D and secondary diabetes and inaugural ketoacidosis) defined by association of the following 3 parameters:
* glucose \> 11 mmol/L or affirmation of having diabetes
* ketonemia \> 3mmol/L or ketonuria ≥ 2
* bicarbonate \< 15 mmol/L and/or venous pH \< or=7.3
* Randomization possible before 15UI of insulin administrated in total
* Informed and written consent. In the absence of parent/ relative/ person of trust, the patient may be included via the emergency procedure and consent will be obtained as soon as possible
Exclusion Criteria:
* Non-diabetic ketoacidosis (fasting or alcoholic)
* Patient weighing less than 30 kg
* Hypokalemia \< 3.5 mmol/L at the time of inclusion
* Hyperosmolar hyperglycemic state (defined as efficient plasma osmolarity \> 320 mosmol/L)
* Absence of social security coverage
* Pregnant or breastfeeding patient
* Patient under tutelage or curators
* Patient deprived of liberty due to a judicial or administrative decision
* Patient with a renal disease requiring dialysis
* Acute or chronic liver failure with Factor V \< 50%
* Patient receiving a high dose of corticosteroids (≥ 0.5 mg/kg) daily
* Patient included in another interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05443802
Study Brief:
Protocol Section:
NCT05443802