Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in childre
Phase 3
Recruiting
- Conditions
- acute phase of diabetic ketoacidosis.Endocrine, nutritional and metabolic diseases.E00-E89
- Registration Number
- IRCT20201125049485N1
- Lead Sponsor
- Qazvin University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
age between 2 to 15 years old
acute diabetic ketoacidosis : BS> 200 mg / dL, PH <7.30 , HCO3 <15 mEq / L ,urinary ketone positive
Exclusion Criteria
• Reluctance to participate in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of exit from the acute phase of diabetic ketoacidosis.Exclusion from the acute phase in this study is a condition in which the serum level is PH> 7.30, HCO3> 15mEq / L, normal serum electrolytes, the patient is conscious and does not vomit. Timepoint: From the time of diagnosis of diabetic ketoacidosis to the time of exit from the acute phase. Method of measurement: Time to hour.
- Secondary Outcome Measures
Name Time Method Determining the average length of hospital stay in the PICU. Timepoint: From the beginning of hospitalization to the time of leaving the PICU. Method of measurement: Time to hour.;Evaluation of side effect from drug use during the study period: Hypoglycemia. Timepoint: From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase. Method of measurement: Frequent laboratory and glucotest monitoring of blood plasma.;Evaluation of side effects due to drug use during the study period: Hypokalemia. Timepoint: From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase. Method of measurement: Laboratory measurement of plasma potassium levels every three hours.;Cerebral edema. Timepoint: From starting treatment for diabetic ketoacidosis to having criteria for exiting the acute phase. Method of measurement: Have any signs or symptoms of high intracranial pressure on clinical examination and vital signs according to international standards.