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Evaluating the effectiveness of pentoxifylline on the prevention of gentamicin nephrotoxicity

Evaluating the effectiveness of pentoxifylline on the prevention of gentamicin nephrotoxicity in hospitalized patients in Shiraz

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161010030246N5
Enrollment
60
Registered
2020-05-08
Start date
2019-07-21
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group: Includes 30 patients, until gentamicin is prescribed, pentoxifylline sustained release 400 mg tablet (Farabi Pharmaceutical Company) is given orally three times a d

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Karimzadeh

Shiraz University of Medical Sciences

karimzadee@sums.ac.ir+98 71 3242 4128

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026