drugset / Trial / NCT05443802

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

NCT05443802

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-08-16
Primary completion
2025-03-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 0.05 iu/kg Intravenous
Subject Insulin Protein / enzyme biologic 0.1 iu/kg Intravenous

Indications