The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach
Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality. The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors . "The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue. Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR \> 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR \<60 dose = 0.19 IU/kg/day.
regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.
Ain Shams University
Cairo, Egypt
RECRUITINGMean time to reversal of diabetic ketoacidosis
Resolution of DKA is defined as blood sugar \<200mg/dl plus any two of serum bicarbonate ≥15,pH\>7.3, and anion gap less than or equal to 12
Time frame: 48 hours
Total crystalline insulin consumption
Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve
Time frame: 48 hours
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