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IRCT20161010030246N5 IRCT 2020-05-08 Shiraz University of Medical Sciences 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 2019-07-21 anticipated 60 Complete https://irct.ir/trial/44131 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 15 blocks to select 60 people. We randomly select these blocks from the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-B-A-A-B-B......, respectively. Finally, group A receives control intervention and group B receives treatment intervention, Blinding description: The researcher is unaware that the medicine given to the patient is the main medicine or placebo. The participant (patient) is also unaware that the medicine being given to them is the main medicine or placebo. 3 Renal toxicity. 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 day. Intervention 2: Control group: Includes 30 patients, until gentamicin is prescribed, placebo 400 mg tablet is given orally three times a day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet. Its release schedule is unclear
public Iman Karimzadeh
Shiraz-Roknabad-Karafarin street-Faculty of Pharmacy
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 4128 karimzadee@sums.ac.ir Shiraz University of Medical Sciences scientific Iman karimzadeh
Department of clinical pharmacy,Namazi hospital,Namazi Squre
Shiraz Iran (Islamic Republic of) 11351 – 71937 +98 71 3647 4332 karimzadee@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 N14 Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions Prevention Prevention Intervention group: Includes 30 patients, until gentamicin is prescribed, pentoxifylline sustained release 400 mg tablet (Farabi Pharmaceutical Company) is given orally three times a day. Control group: Includes 30 patients, until gentamicin is prescribed, placebo 400 mg tablet is given orally three times a day. 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. Serum level of TNF-α. Timepoint: Serum level of TNF-α is measured before starting gentamicin treatment (day 0) and day 7 of gentamicin treatment. Method of measurement: Measurement of TNF-α 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. Shiraz University of Medical Sciences Approved 2019-07-20 Ethics committee of Shiraz University of Medical Sciences Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)