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IRCT20211220053468N1 IRCT 2022-06-12 Shahid Beheshti University of Medical Sciences Effect of Glucose-Insulin-Potassium in Creatine Phosphokinase (CPK) Evaluation of the effect of Glucose-Insulin-Potassium to decrease level of Creatine Phosphokinase (CPK) in multiple trauma patients 2022-06-22 anticipated 70 Complete https://irct.ir/trial/63863 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method of the samples will be based on the simple randomization method and using a random number table, and the central randomization method will be used to hide the random allocation. The method is as follows: a non-involved person in the study reads the numbers from a table of random numbers (based on the total sample size of 70 people) from top to bottom, assigns even numbers to the drug solution of the control group and the odd numbers to the intervention group. As a result, the study drug combination or placebo is randomly selected based on the table. Each solution is then encrypted separately with a code. Clinical caregivers, who are different from the person preparing the drug combination, receive a coded solution (which can be a drug combination or placebo) when the patient is eligible for the study. Clinical caregivers do not know the order of the random number table and the number of samples, etc. Also, the person preparing the drug solution does not know the conditions of the patients and prepares the solution only based on the table of random numbers, Blinding description: Patients enter the study after explaining how to do the study and obtaining consent. the drug combination of the control and intervention groups is prepared by the non-involved person in the study and the content of the solutions is hidden by entering the code, so patients, clinicians, researchers, evaluators and analysts are blind to the content of each solution. Patients are only aware of the possibility of accidentally receiving two types of treatment for their disease, and their conditions and side effects, and do not know to which study group they are assigned, so they are blind to their study group. After analyzing the information, the groups are divided according to the code allocated for study analysis. N/A Trauma, Rhabdomyolysis. Intervention 1: Intervention group: In this group, on the first and second day of the study, the pre-prepared solution, including a 50 ml vial of 50% Dextrose plus 10 units of regular Insulin plus 10 mmol of Potassium, is added to the patient's fluid intake as a single dose, which all patients receive as approved treatment. Intervention 2: Control group: In this group, No intervention is performed and only approved treatment is continued,that is, twice the amount of maintenance fluid (which according to the formula, the first 10 Kg of the patient's weight is equal to 100 ml/Kg and the second 10 Kg of the patient's weight is equal to 50 ml/Kg and the rest of the patient's weight is equal to 20 ml/Kg) Normal saline is administered as a 24-hour intravenous fluid. Yes - There is a plan to make this available What will be shared: Individual background data can be shared after unidentified individuals, the resulting data file can be published. When: Access is 6 months after the publication of the relevant article To whom: Researchers of scientific institutes Conditions: For scientific research Where to obtain: Communication with people responsible for scientific and public accountability How to obtain: After receiving the request and confirming the identity, information can be provided according to the type of requested information. Comments:
public Reza Beheshti Monfared
Madani Ave.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 r_beheshti_m@yahoo.com Shahid Beheshti University of Medical Sciences scientific Sara Salarian
Shahid Madani Ave.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 sarasalarian@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Trauma patient More than 18 years old Satisfaction with participation in the study CPK>3000 Urine output ≥ 0.5 cc/kg/hour 18 years no limit Both Absence of Angina, history of Malignant Hyperthermia, history of Myocarditis, Muscular Dystrophy, Rheumatoid Arthritis, Liver disease, Connective tissue disease, Heart failure Absence of Shock( BP more than 90 mmHg) Absence of Hypo- or Hyperglycemia( BS 100-250) Absence of Hypo- or Hyperkalemia( K 2.8 - 5) Treatment - Drugs Treatment - Drugs Intervention group: In this group, on the first and second day of the study, the pre-prepared solution, including a 50 ml vial of 50% Dextrose plus 10 units of regular Insulin plus 10 mmol of Potassium, is added to the patient's fluid intake as a single dose, which all patients receive as approved treatment. Control group: In this group, No intervention is performed and only approved treatment is continued,that is, twice the amount of maintenance fluid (which according to the formula, the first 10 Kg of the patient's weight is equal to 100 ml/Kg and the second 10 Kg of the patient's weight is equal to 50 ml/Kg and the rest of the patient's weight is equal to 20 ml/Kg) Normal saline is administered as a 24-hour intravenous fluid. Level of blood creatine phosphokinase (CPK). Timepoint: Creatine phosphokinase (CPK) blood levels are measured on the first day of the study (before the intervention) and on the first and second days after. Method of measurement: Creatine phosphokinase levels in blood samples are measured in a hospital laboratory. Blood creatinine level. Timepoint: Creatinine blood levels are measured on the first day of the study (before the intervention) and on the first and second days after. Method of measurement: Blood samples are measured in hospital laboratory. Blood potassium. Timepoint: Blood potassium levels are measured on the first day of the study (before the intervention) and on the first and second days after. Method of measurement: Blood samples are measured in hospital laboratory. Blood sugar. Timepoint: Blood sugar levels are measured on the first day of the study (before the intervention) and on the first and second days after. Method of measurement: Blood samples are measured in hospital laboratory. Shahid Beheshti University of Medical Sciences Approved 2022-05-24 Research Ethics Committees of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Arabi Ave, Yaman Ave, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)