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IRCT20220326054351N1 IRCT 2022-08-30 Sabzevar University of Medical Sciences The prophylactic effect of theophylline on vancomycin-induced nephrotoxicity Investigating the effect of theophylline on vancomycin-induced nephrotoxicity in children aged one month to 18 years with severe infection compared to vancomycin alone. 2022-08-23 anticipated 34 Complete https://irct.ir/trial/62667 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, all children with severe infection, including meningitis and septicemia, who are treated with vancomycin are included. In this method, we have two treatment groups, where T is considered as the group receiving theophylline and vancomycin, and C is considered as the group receiving vancomycin. Including blocks of four, we will have six modes that we use in the form of six cards with a replacement for random allocation. These six modes are as follows. TTCC, TCTC, CTTC, CTCT, TCCT, CCTT For a sample size of 34 to 9 times, we use the above cards with replacement, Blinding description: The method of blinding is single-blinding. The researcher knows how to allocate drugs to the samples. The laboratory expert does not know how to allocate the drugs to the samples. The evaluator of laboratory results, is a person who is not aware of the treatment allocation. The outcome is evaluated objectively, so there is no necessity to blind the patient. 2-3 nephrotoxicity. Intervention 1: Intervention group:Patients are treated with vancomycin and theophylline. Vancomycin is prescribed at a dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.) Depending on which form of theophylline the child is able to take, syrup or tablets are chosen. Theophylline is prescribed daily at a dose of 5 mg/kg and lasts for three days.(Theochal-G syrup made by Alborz Drug Company or theophylline tablet E.R. 200 made by Razak Laboratory Company.). Intervention 2: Control group:pattients are only treated with vancomycin. Vancomycin is prescribed with dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.). Yes - There is a plan to make this available What will be shared: All data can be anonymized after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: Everyone is allowed to access the data. Conditions: In order to reanalyze and use the data in larger scale studies conducted by other researchers. Where to obtain: Dr.Aghil-allah Keykhosravi drakeykhosravi@yahoo.com How to obtain: The request should be made through the provided email Comments:
public Aghil Keykhosravi
Heshmatieh hospital, Asad-abadi ST.
Sabzevar Iran (Islamic Republic of) 9619795591 +98 51 4401 1600 drakeykhosravi@yahoo.com Sabzevar University of Medical Sciences scientific Aghil-allah Keykhosravi
Heshmatieh hospital, Asad-abadi ST.
Sabzevar Iran (Islamic Republic of) 9619795591 +98 51 4401 1600 drakeykhosravi@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Patients with systemic infection treated with vancomycin Patients one month to 18 years Complete the informed consent form 1 month 18 years Both Patients who are discharged from the hospital before three days. Patients with unpredictable complications. Patients with drug side effects. Prevention Other Intervention group:Patients are treated with vancomycin and theophylline. Vancomycin is prescribed at a dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.) Depending on which form of theophylline the child is able to take, syrup or tablets are chosen. Theophylline is prescribed daily at a dose of 5 mg/kg and lasts for three days.(Theochal-G syrup made by Alborz Drug Company or theophylline tablet E.R. 200 made by Razak Laboratory Company.) Control group:pattients are only treated with vancomycin. Vancomycin is prescribed with dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.) The percentage of people treated with vancomycin who develop microalbuminuria. Timepoint: Measurement of microalbuminuria at the beginning of the study and 72 hours after starting treatment with vancomycin. Method of measurement: Measurement of microalbuminuria in urine sample.The range is 30-300 mg per 24 hours. The percentage of people treated with vancomycin who experience an increase in urea and creatinineCommunity Verified icon. Timepoint: Measurement of urea and creatinine at the beginning of the study and 72 hours after starting vancomycin treatment. Method of measurement: Measurement of urea and creatinine in serum samples.Depending on the patients age, urea 20-30 mg/dL and creatinine 0.4-1 mg/dL. Patient weight change. Timepoint: before treatment & after three days from the start of treatment. Method of measurement: Measuring the patient's weight in kilograms with a digital scale. Sabzevar University of Medical Sciences Approved 2022-01-02 Ethics committee of Sabzevar University of Medical Sciences No. 196, Al-ahmad sq., Sabzevar Razavi Khorasan Iran (Islamic Republic of)