Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).

Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.

During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.

The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Insulin; Insulin, Globin Zinc

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 within 2 hours of insulin initiation

• 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