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IRCT20130917014693N16 IRCT 2023-01-26 Shahid Beheshti University of Medical Sciences Evaluation of vancomycin dosing regimen in patients with acute kidney injury Comparison of pharmacokinetic parameters and clinical outcomes of vancomycin administered in two different dosage regimens in patients with acute kidney injury 2023-03-20 anticipated 28 Complete https://irct.ir/trial/67549 observational Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. patients are placed in to two control and intervention groups using a table of random numbers in a ratio of 1:1. To use the table of random numbers, a column and a row are randomly selected, and the 2 digits on the left side of the crossing point is the first selected number. A hypothetical plus is drawn from that number and the numbers placed in that plus are selected. This process continues until half of the total number of samples is selected, and this numbers will determine the intervention group. 3 Acute kidney injury. Intervention 1: Control group: patients in this group will be received Vancomycin with the dose of 15-20 mg/kg every 12 hour over 60 minute infusion as empiric or targeted therapy. Intervention 2: Intervention group: patients in this group will be received adjusted dose of vancomycin based on creatinine clearance (Cockcroft-Gault equation). patients with creatinine clearance 5 to 50 milliliter/minute will receive 10 to 15 milligram/kilogram daily and patients with creatinine clearance less than 25 milliliter/minute will receive 10 to 15 milligram/kilogram every 48 hours. These patients will be visited everyday to make sure they've been received corrected and daily adjusted doses of vancomycin. creatinine clearance= [140 - age(years)] / 72cr. the calculated creatinine clearance should be multiplied by 0.85 if female. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after results published To whom: academic institution's researchers Conditions: research purposes and meta-analysis Where to obtain: Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, Makhsoos St, Tehran How to obtain: official letter to researchers Comments:
public Zahra Sahraei
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Valieasr St, Niyayesh Highway
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 z.sahraei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Zahra Sahraei
Valieasr St, Niyayesh Highway, Shahid Beheshti University of Medical Sciences, School of Pharmacy
Tehran Iran (Islamic Republic of) 1996835113 +98 21 8887 3704 z.sahraei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Receiving at least four doses of vancomycin Suffering from acute kidney injury according to KDIGO guideline while receiving vancomycin as said 18 years no limit Both Pregnant or breastfeeding Younger than 18 years old History of chronic kidney disease History of vancomycin allergy N17.9 Acute renal failure, unspecified Treatment - Drugs Treatment - Drugs Control group: patients in this group will be received Vancomycin with the dose of 15-20 mg/kg every 12 hour over 60 minute infusion as empiric or targeted therapy. Intervention group: patients in this group will be received adjusted dose of vancomycin based on creatinine clearance (Cockcroft-Gault equation). patients with creatinine clearance 5 to 50 milliliter/minute will receive 10 to 15 milligram/kilogram daily and patients with creatinine clearance less than 25 milliliter/minute will receive 10 to 15 milligram/kilogram every 48 hours. These patients will be visited everyday to make sure they've been received corrected and daily adjusted doses of vancomycin. creatinine clearance= [140 - age(years)] / 72cr. the calculated creatinine clearance should be multiplied by 0.85 if female. Percentage of patients who reach therapeutic target of Area under the curve (AUC)/Minimum inhibitory concentration (MIC) over 400. Timepoint: First and forth day of study. Method of measurement: measuring plasma level of vancomycin with ECL Immunoassay method. Clinical condition improvement like the rate of fever or mortality. Timepoint: daily. Method of measurement: observation. Shahid Beheshti University of Medical Sciences Approved 2022-10-25 Ethics committee of Shahid Beheshti University of Medical Science 3rd floor, school of medicine, Evin St, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)