Protective effect of oral nano-silymarin on vancomycin-induced nephrotoxicity
- Conditions
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- Registration Number
- IRCT20200408046990N9
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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 ...
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.