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IRCT20130917014693N15 IRCT 2023-01-12 Shahid Beheshti University of Medical Sciences Evaluating the effects of magnesium in colistin nephrotoxicity Evaluating the effect of intravenous magnesium sulphate for prevention of colistin induced Acute Kidney Injury 2023-01-21 anticipated 96 Complete https://irct.ir/trial/67555 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization method with aim of elimination of the nephrotoxic effects of vancomycin (the other routinely used nephrotoxic antibiotics) is used. Therfore, this study is designed in 2 blocks of "with and without vancomycin". In each block (with an equal number of patients), patients are placed in two control and intervention groups using a table of random numbers in a ratio of 1:1. The calculated number of samples is 96 patients, which are numbered from 1 to 96 according to the sampling time. 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 (48 numbers) is selected, and this numbers will determine the intervention group. The first 24 numbers will be in the intervention group of "with vancomycin" block and the second 24 numbers will be in theintervention group of "without vancomycin" block. 3 Acute Kidney Injury. Intervention 1: Intervention group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval. In the intervention group, one hour before receiving each dose of colistin, 2g (16~mEq) intravenous magnesium sulfate (dissolved in 50 ml of normal saline) is infused within one hour. Intervention 2: Control group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after blinding. When: Six months after the results are published To whom: Academic institution's researchers Conditions: Research purposes and meta-analysis Where to obtain: Dr. Zahra Sahraei, Loghman Hakim Hospital, Kamali St, South Kargar 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) Patients with indication of colistin therapy patients with GFR> 60ml/min patients with magnesium blood level between 1.9 and 3 mg/dl 18 years no limit Both patients younger than 18 years patients with GFR< 60ml/min patients with magnesium blood level of less than 1.9 or more than 3 mg/dl Pregnant patients N17.9 Acute kidney failure, unspecified Prevention Prevention Intervention group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval. In the intervention group, one hour before receiving each dose of colistin, 2g (16~mEq) intravenous magnesium sulfate (dissolved in 50 ml of normal saline) is infused within one hour. Control group: Colistin therapy begins with a dose of 9-12 million IU as 1-hr infusion and maintenance therapy continues after 12 hours of the loading dose, with a daily dose of 9-12 million IU divided into two infusions with 12-hour interval. Acute Kidney Injury occurrence. Timepoint: Daily during the first week of colistin therapy. Method of measurement: The Kidney Disease Improving Global Outcomes (KDIGO) criteria for Acute Kidney Injury. Escalation or de-escalation of therapy. Timepoint: Daily during the first week of colistin therapy. Method of measurement: Colistin daily dose observation. Length of hospitalization. Timepoint: At the time of discharge. Method of measurement: Counting the number of days. Death. Timepoint: Daily. Method of measurement: Records Observation. Shahid Beheshti University of Medical Sciences Approved 2022-10-25 Ethics committee of shahid beheshti university of medical sciences 3rd floor, medical school, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)