Evaluating the effectiveness of pentoxifylline on the prevention of gentamicin nephrotoxicity

Phase 3

Recruiting

Conditions: Renal toxicity.
Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

Registration Number: IRCT20161010030246N5

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age higher than 18 years
Receiving intravenous or intramuscular gentamicin for at least 1 week
No confirmed acute or chronic kidney injury
Do not take gentamicin intravenously or intramuscularly during the past 14 days
Do not take pentoxifylline orally during the past week
No confirmed history of allergic reactions to pentoxifylline
Informed consent form

Exclusion Criteria

Patient with hemodynamic instability
Concomitant use of medicines or antioxidant compounds such as vitamin C, vitamin E, or vitamin A
Concomitant use of medications with high renal toxicity
No tolerant of oral medications

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gentamicin nephrotoxicity is defined by either a rise in the plasma creatinine concentration of more than 0.5 to 1 mg/dL. Timepoint: Serum creatinine is measured before starting gentamicin treatment (day 0) and days 1, 3, 5, and 7 of gentamicin treatment. Method of measurement: Measurement of serum creatinine is done by using an autoanalyzer device.;Hypokalemic electrolyte disorder (serum level potassium below 3 mEq/L). Timepoint: Serum potassium level are determined before starting gentamicin treatment (day 0) and days 1, 3, 5, and 7 of gentamicin treatment. Method of measurement: Measurement of Serum potassium level is done by using an autoanalyzer device.;Hypomagnesemia electrolyte disorder (serum magnesium level below 1.2 mEq/L). Timepoint: Serum magnesium level are determined before starting gentamicin treatment (day 0) and days 1, 3, 5, and 7 of gentamicin treatment. Method of measurement: Measurement of Serum magnesium level is done by using an autoanalyzer device.

Secondary Outcome Measures

Name	Time	Method
Serum level of TNF-a. Timepoint: Serum level of TNF-a is measured before starting gentamicin treatment (day 0) and day 7 of gentamicin treatment. Method of measurement: Measurement of TNF-a is done by the ELISA method.;Serum level of malondialdehyde. Timepoint: Serum level of malondialdehyde is measured before starting gentamicin treatment (day 0) and day 7 of gentamicin treatment. Method of measurement: Measurement of malondialdehyde is done by the ELISA method.