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IRCT20161010030246N6 IRCT 2023-05-27 Shiraz University of Medical Sciences Evaluating the effectiveness of silymarin in preventing vancomycin nephrotoxicity Evaluating the effectiveness of silymarin in preventing vancomycin-induced nephrotoxicity in hospitalized patients 2023-06-13 anticipated 80 Complete https://irct.ir/trial/70310 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization (quadruple blocks): All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB. We need 20 blocks to select 80 people. We randomly select these blocks from the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-B-A-A-B-B, respectively. Finally, group A receives placebo and group B receives silymarin, Blinding description: The researcher does not know whether the drug he gives to the patient is a placebo or the original drug. On the other hand, the participant (patient) is also unaware of whether the drug given to him is a placebo or the original drug. 3 Vancomycin-induced nephrotoxicity in hospitalized patients. Intervention 1: Intervention group: In this group, as long as vancomycin is received, silymarin tablets from the Gol Daru company (Livergol) are prescribed orally in the amount of 140 mg three times a day orally. Intervention 2: Control group: In this group, along with vancomycin, placebo tablets 140 mg three times a day are given orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست
public Iman Karimzadeh
Shiraz, Rokn Abad, Karafan St., Faculty of Pharmacy
shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 karimzadee@sums.ac.ir Shiraz University of Medical Sciences scientific Iman Karimzadeh
Namazi Square, Namazi Hospital, Clinical Pharmacy Department Office
shiraz Iran (Islamic Republic of) 1135171937 +98 71 3647 4326 karimzadee@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Hemodynamic stability (mean arterial blood pressure above 70 mmHg and/or systolic blood pressure above 90 mmHg. Willingness to participate in the study Receiving vancomycin intravenously for at least 1 week with the maintenance dosage regimen of 30-45 mg/kg/day or 1-2 g twice a day. Notably, the vancomycin regimen is the same in both hospitals. 18 years no limit Both Confirmed history of acute kidney injury Confirmed history of chronic kidney disease Taking vancomycin within the last 14 days Taking silymarin orally at least during the past day Confirmed history of hypersensitivity reactions following oral consumption of silymarin Simultaneous use of agents with antioxidant activity such as vitamin C, vitamin E, vitamin A, melatonin Receiving drugs with high nephrotoxicity potential such as aminoglycosides, amphotericin b, colistin Oral intolerance to drugs N14 Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions Prevention Prevention Intervention group: In this group, as long as vancomycin is received, silymarin tablets from the Gol Daru company (Livergol) are prescribed orally in the amount of 140 mg three times a day orally. Control group: In this group, along with vancomycin, placebo tablets 140 mg three times a day are given orally. Vancomycin nephrotoxicity as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hrs or an increase in serum creatinine to ≥ 1.5 times baseline within the previous seven days. Timepoint: Sampling of urine and blood (5 ml) of patients will be done before starting the drug (day zero) and on days 1, 2, 3, 5, 7, 10, and 14 of vancomycin treatment. Method of measurement: Measurement of serum creatinine is done by using an autoanalyzer instrument. Acute tubular necrosis is defined as fractional excretion of sodium more than 2% in the absence of diuretic treatment. Timepoint: Sampling of urine and blood (5 ml) of patients will be done before starting the drug (day zero) and on days 1, 2, 3, 5, 7, 10, and 14 of vancomycin. Method of measurement: Measurement of serum as well as urine creatinine along with serum as well as urine sodium is done by using an autoanalyzer instrument. Serum level of malondialdehyde, total antioxidant capacity, and glutathione. Timepoint: At days 0 and 14 of vancomycin treatment. Method of measurement: Serum level of malondialdehyde, total antioxidant capacity, and glutathione are measured by the ELISA technique. Shiraz University of Medical Sciences Approved 2023-05-21 Ethics Committee of Shiraz Medical Sciences Research and Technology Vice-Chancellor of Shiraz University of Medical Sciences-Shiraz Zand Street-Central Building of Shiraz University of Medical Sciences-7th Floor-Research and Technology Vice-Chancellor shiraz Fars Iran (Islamic Republic of)