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

Determining the efficacy of pentoxifylline in the prevention of renal toxicity caused by gentamicin in hospitalized patients in Shiraz

This study is a double-blinded, placebo-controlled, randomized clinical trial. The sample size is 60 patients. In this study, there is no factor in the classification of patients in the two groups.

A multi-center, randomized, double-blinded, placebo-controlled clinical trial is performed in ُShiraz educational hospitals such as Namazi and Shahid Faghihi. Serum creatinine, potassium, and magnesium levels are measured before starting gentamicin treatment (day 0) and days 1, 3, 5, and 7 of gentamicin treatment. Serum levels of malondialdehyde and TNF-α are measured before starting gentamicin treatment (day 0) and day 7 of gentamicin treatment.

Inclusion criteria: Receiving intravenous or intramuscular gentamicin for at least 1 week; Lack of 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; Lack of confirmed history of allergic reactions to pentoxifylline; Signing up the 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; Lack of oral tolerance to medications.

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

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.

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.