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Conditions
Interventions
Intervention 1: Intervention group: silymarin softgel prepared by Exir nano Sina Inc. Company twice a day (after breakfast and dinner) for 14 days or until vancomycin is discontinued (There is no rou
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age between 18 to 60 Take vancomycin at a dose of 15-20 mg / kg two to three times a day for at least one week Signing a written consent by the patient Creatinine clearance greater than 90 ml/min based on Cockcroft-Gault formula
Exclusion criteria
Exclusion criteria: Underlying renal impairment such as glomerulonephritis, polycystic kidney disease, renal stone, interstitial nephritis, renal artery stenosis and renal carcinoma Receive nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, tacrolimus and furosemide, etc. simultaneously History of allergy to products containing silymarin History of acute kidney injury Pregnancy and lactation Consumption of vitamin and herbal antioxidant supplements such as vitamins C and E or curcumin and ...
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vancomycin nephrotoxicity (increase of 0.3 mg/dl for two consecutive days). Timepoint: At baseline (before intervention) and on days 3, 7, 10 and day 14. Method of measurement: Serum creatinine level is measured by Jaffe method.;Serum creatinine and BUN levels. Timepoint: At baseline (before intervention) and on days 3, 7, 10 and day 14. Method of measurement: Serum creatinine level is measured by Jaffe method.;Serum cystatin C levels. Timepoint: Serum levels of cystatin C on days 3 and 7. Method of measurement: turbidimetry method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of onset of nephrotoxicity. Timepoint: Days 0, 3, 7, 10, 14, 21 after starting vancomycin. Method of measurement: For nephrotoxicity, serum creatinine level is measured by Jaffe method and serum cystatin C level is measured by turbidometry method.;Duration of hospitalization. Timepoint: Daily during treatment. Method of measurement: clinical evaluation of the physician will be performed during treatment.;Occurrence of other side effects of vancomycin including Red Man syndrome and hematological complications, etc., as well as occurrence of silymarin side effects such as gastrointestinal complications. Timepoint: Daily during treatment. Method of measurement: For blood and gastrointestinal complications, CBC test and clinical evaluation of the physician will be performed during treatment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactVahid Soleimani
Mashhad University of Medical Sciences
Outcome results
None listed