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IRCT20120415009475N12 IRCT 2022-07-05 Shahid Beheshti University of Medical Sciences Comparison of continuous and intermittent infusion administration methods of Vancomycin Comparison of Vancomycin Area Under the Curve (AUC) in Continuous and Intermittent Infusion Regimens in Pediatric Patients Admitted to the Intensive Care Unit 2022-08-23 anticipated 72 Complete https://irct.ir/trial/64433 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Block randomization method will be used in this study. Eighteen blocks including four patients will be generated with the online website (www.sealedenvelope.com/simple-randomiser/v1). In each block, two patients will be randomly assigned to the continuous infusion group and two patients will be assigned to the intermittent infusion group, Blinding description: The patient data will be in coded same packages; a designated person will provide the codes from permuted block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis. After the results, the pocket with the randomization provider will be opened, and the data will be decrypted. The data regarding the harm and benefits of treatment groups will be provided to the patient and caregiver. 3 Proven or suspected Infection with methicillin resistant staphylococcus aureus candidate for Vancomycin Treatment. Intervention 1: Intervention group: Vancomycin will be given as a loading dose of 15 mg/kg followed by a continuous infusion of 60 mg/kg over 24 hours. Intervention 2: Control group: Vancomycin will be given at a dose of 15 mg/kg every 6 hours. Yes - There is a plan to make this available What will be shared: The main outcome will be available When: Six months after publishing To whom: The data will be available per request for people working in academic institutions Conditions: The data will available for using in systematic review and meta-analysis Where to obtain: The data will be available by contacting email; mirrahimi@sbmu.ac.ir How to obtain: The data will available for using in systematic review and meta-analysis Comments:
public Baran roshan
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Niayesh junction, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2222 7029 baranroshann@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.,
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 2 months to 15 years old Weight under 67 kg Central venous access Obtaining written consent from a legal guardian 2 months 15 years Both Renal impairment, GFR<50 ml/min (Schwartz formula) Need for hemodialysis or CRRT Need for extracorporeal membrane oxygenation or plasmapheresis Loss of Central venous access Lysis of blood samples Discontinuation of vancomycin before 3 days of administration due to clinical judgment Retraction of consent by legal guardian A49.02 Methicillin resistant Staphylococcus aureus infection, unspecified site Treatment - Drugs Treatment - Drugs Intervention group: Vancomycin will be given as a loading dose of 15 mg/kg followed by a continuous infusion of 60 mg/kg over 24 hours Control group: Vancomycin will be given at a dose of 15 mg/kg every 6 hours. Serum level of vancomycin. Timepoint: Third day of receiving vancomycin. Method of measurement: Fluorescence Polarization Immunoassays. Clinical response. Timepoint: 5 Days. Method of measurement: Use the Pediatric Sequential Organ Failure Assessment score and Pediatric Risk of Mortality III score to predict mortality in the pediatric intensive care unit. Duration of ICU stay. Timepoint: 1 Month. Method of measurement: Day. Shahid Beheshti University of Medical Sciences Approved 2022-01-25 Ethics Committee of Schools of Pharmacy, Nursing and Midwifery Shahid Beheshti University of Medic 2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction Tehran Tehran Iran (Islamic Republic of)