Evaluating the effectiveness of silymarin in preventing vancomycin nephrotoxicity

Phase 3

Conditions: Vancomycin-induced nephrotoxicity in hospitalized patients.
Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

Registration Number: IRCT20161010030246N6

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.