Vancomycin-induced nephrotoxicity in hospitalized patients. Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions
Conditions
Interventions
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
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactIman Karimzadeh
Shiraz University of Medical Sciences
Outcome results
None listed