]>
IRCT2012091110817N1 IRCT 2013-01-24 Tehran University of Medical Sciences Detection of amikacin nephrotoxicity with novel markers Using novel biomarkers for detection and comparison of nephrotoxicity induced by various doses of amikacin in geriatric critically ill patients: A randomized clinical trial 2012-06-21 anticipated 40 Complete https://irct.ir/trial/11230 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A sepsis. Intervention 1: patients devided in 2 groups and in one group (high dose group) amikacin by dose of 25 mg/kg based on IBW will be administered to the patients. serum and urine samples will be collected on baseline and days 3.5.7. and 10 of the study. Intervention 2: In second group ( standard dose group) amikacin by dose of 15 mg/kg based on IBW will be administered for the patients for 10 days and serum and urine sampl;es will be collected on baseline and days 3,5,7, and 10 for analysis.
public Kourosh Sadeghi
Department of Clinical Pharmacy- School of Pharmacy- Tehran University of Medical Sciences- Enghelab Sq. Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 6695 4709 sadeghik@razi.tums.ac.ir Tehran University of Medical Sciences scientific Professoe Mojtaba Mojtahedzadeh
School of Pharmacy and Sina Hospital, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6695 4709 mojtahed@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: age equal to or more than 65; serum creatinin equal to or less than 1.2 or estimated GFR equal to or more than 40 ml/min; sepsis with gram negative or unknown microorganism in geriatric patients addmited in ICU and need for an aminoglycoside and no history of aminoglycoside administration in the last 30 days. Exclusion criteria: age less than 65; aminoglycoside administration in the last 30 days; BMI more than 35; Allergy to aminoglycosides; amikacin administration less than 5 days; trouph levels more than 10 mcg/ml; need for amikacin dose adjustment during study period; neoplasm diagnisis with chemotherapy or radiotherapy history; viral hepatitis; moderate to severe renal failure considering normal decline in GFR with aging ( Scr more than 1.2); life expectancey less than 48 hours and APACHE II score more than 35. 65 years no limit Both A 41.5 Sepsis due to other Gram-negative organisms Treatment - Drugs Treatment - Drugs patients devided in 2 groups and in one group (high dose group) amikacin by dose of 25 mg/kg based on IBW will be administered to the patients. serum and urine samples will be collected on baseline and days 3.5.7. and 10 of the study In second group ( standard dose group) amikacin by dose of 15 mg/kg based on IBW will be administered for the patients for 10 days and serum and urine sampl;es will be collected on baseline and days 3,5,7, and 10 for analysis. Akutre kidney injury incidence. Timepoint: baseline and during drug administration on days: 3, 5 , 7, 10. Method of measurement: measurment of AKI biomarkers and serum creatinine. Survival after 28 days post intervention in two groups. Timepoint: 28 days after initiation of study. Method of measurement: report of survival or mortality on day 28. Tehran University of Medical Sciences Approved 2012-11-18 research ethics comitee of Tehran University of Medical Sciences Tehran University of Medical sciences, enghelab Sq, Tehran, Iran Tehran Iran (Islamic Republic of)