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IRCT20201125049485N1 IRCT 2021-01-05 Qazvin University of Medical Sciences Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children DKA Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children 2020-11-11 anticipated 108 Complete https://irct.ir/trial/52557 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: after providing a full explanation of the method and purpose of the research, the children's parents sign the consent form and the basic information is entered into a questionnaire. This information includes Age, weight, height, stage of puberty, history and severity of the disease . patients are divided into One of three groups of control and intervention using random block sampling method.Two intervention groups: Children who, in addition to receiving short-term standard insulin drip within the first 6 hours of treatment, receive a long-acting subcutaneous dose of Lantus or Detmirra at a rate of 0.5 units per kilogram of body weight .In both groups,Time out of the acute phase and the occurrence of complications are recorded , the duration of exit from the acute phase, the length of stay of the child in the intensive care unit and the occurrence of possible complications are reviewed and recorded. Exclusion from the acute phase in this study is a condition in which the serum level is PH> 7.3, HCO3> 15mEq / L, normal serum electrolytes, the patient is conscious and does not vomit. The serum level of patients' blood sugar is measured and recorded by the glucometer every hour and the level of blood sugar, sodium, potassium and VBG (Venus blood gas) of patients is measured and recorded by the laboratory every three hours. Finally, the collected data are compared with each other and the findings are reported. All patient information will remain confidential with the researchers and the findings of this study will be reported anonymously, Randomization description: All children with diatotic ketoacidosis who are referred to Qazvin Children's Hospital for treatment are included in the study based on inclusion and exclusion criteria. Then patients are assigned to one of the 3 treatment groups based on the block random allocation table which is randomly assigned to the software. Therefore, we have 18 blocks, in each block of 6, the number of patients assigned to each treatment group is equal to 2, Blinding description: In this study, the clinical caregiver (physician and nurse) is aware of the intervention due to the registration of the intervention in the physician's instructions , But the researcher, data analyzer, and outcome assessor do not know which patient is in the intervention or control group. 3 acute phase of diabetic ketoacidosis. Intervention 1: Intervention group 1: Children who in the first 6 hours of treatment, in addition to receiving short-term standard insulin drip, receive a long dose of subcutaneous insulin effect of Detmir with a rate of 0.5 units per kilogram of child weight . Intervention 2: Control group: Standard treatment for diabetic ketoacidosis in children, including short-acting intravenous insulin, is prescribed. Intervention 3: Intervention group 2: Children who in the first 6 hours of treatment, in addition to receiving standard short-term insulin drip, receive a long-acting subcutaneous insulin dose of Lantus at a rate of 0.5 units per kilogram of child weight. Yes - There is a plan to make this available What will be shared: The course of treatment and the main outcome of the intervention and possible complications When: Simultaneously with the publication of the article To whom: Universities of Medical Sciences Conditions: Mention the data source in future research Where to obtain: Qazvin Children's Hospital Hospital Research Center Phone 0283333480 How to obtain: Submitting a written request to the hospital research assistant Comments:
public Victoria Chegini
Shahid Beheshti Blvd
Qazvin Iran (Islamic Republic of) 4595-1-34159 +98 28 3333 4807 victoria_che@yahoo.com Qazvin University of Medical Sciences scientific Victoria Chegini
Shahid Beheshti Blvd
Qazvin Iran (Islamic Republic of) 4595-1-34159 +98 28 3333 4808 victoria_che@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) age between 2 to 15 years old acute diabetic ketoacidosis : BS> 200 mg / dL, PH <7.30 , HCO3 <15 mEq / L ,urinary ketone positive 2 years 15 years Both • Reluctance to participate in the study E00-E89 Endocrine, nutritional and metabolic diseases. Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Children who in the first 6 hours of treatment, in addition to receiving short-term standard insulin drip, receive a long dose of subcutaneous insulin effect of Detmir with a rate of 0.5 units per kilogram of child weight . Control group: Standard treatment for diabetic ketoacidosis in children, including short-acting intravenous insulin, is prescribed Intervention group 2: Children who in the first 6 hours of treatment, in addition to receiving standard short-term insulin drip, receive a long-acting subcutaneous insulin dose of Lantus at a rate of 0.5 units per kilogram of child weight 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. 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. Qazvin University of Medical Sciences Approved 2020-11-11 Ethics committee of Qazvin University of Medical Sciences Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)