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IRCT20240729062573N1 IRCT 2024-09-16 Yazd University of Medical Sciences The effect of vancomycin loading dose in diabetic foot patients Evaluation of vancomycin loading dose effect on clinical outcome in patients with diabetic foot infection: a randomize, double blind clinical trial 2024-09-22 anticipated 80 Complete https://irct.ir/trial/78247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 80 patients This number of patients were selected by randomization method based on permutation block and will be divided into two groups of 40 people Group A received vancomycin loading dose and then receive maintainace doses and in front of B group They only received maintenance doses In both groups, the doses of potency are determined based on the gfr of the patients from the beginning to the end of the study Every patient is visited daily, Blinding description: A double-blind study is such that all the above steps will be hidden from the view of the patient and the attending physician, all patients entered into the study have completed the consent form before being assigned to the two study groups, but from their assignment to the control group or They are unaware of medicine. The first operator determines the sequence and specific plan of the patients according to the order of entering the patients into the study and identifies them with code A or B, then determines the appropriate medicine for each person according to the above explanations and places them in special envelopes. The nurse injects it. 3 Investigating the effect of vancomycin loading dose in diabetic foot patients. Intervention 1: Forty drug candidate patients receiving Laoding dose with a dose (20-35 mg/kg) of 25 mg/kg vancomycin (vancomycin injection vial of Dena Pharmaceutical Company) (maximum 2 grams, even in patients with a weight of more than 80 kg, a loading dose of more than 2 grams was given (can't) infusion within 2 hours and then receiving a maintenance dose (15-20 mg/kg/dose every 8 to 12 hours) in the amount of 500 to 2000 mg (for every 500 mg of vancomycin, infusion should be done for 30 minutes) Based on the GFR calculated from the Cockrauf-Gault formula,. Intervention 2: Control group: forty drug candidate patients without receiving the loading dose of vancomycin (without receiving the loading dose) received maintenance doses of vancomycin (Vancomycin injection vial of Dana Pharmaceutical Company) with a dose of 15-20 mg/kg/dose every 8 to 12 hours (calculated based on GFR from the Cockrauf-Gault formula) and the infusion rate should be 30 minutes per 500 mg of vancomycin. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nazanin Nematelahi
Faculty of Medicine,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۹۶۵۵۱ +98 35 3820 3865 Nematelahinazanin@gmail.com Yazd University of Medical Sciences scientific Nazanin Nematelahi
Faculty of Faculty of Medicine, Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
Yazd Iran (Islamic Republic of) ۸۹۱۵۸۹۶۵۵۱ +98 35 3820 3865 Nematelahinazanin@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Diabetic patients over 18 years of age with purulent drainage, swelling, and redness in the leg area below the knee who are admitted to the infectious department of Shahid Sadoughi Hospital in Yazd and are candidates for treatment with vancomycin injection form to treat diabetic foot infection Receive vancomycin for at least 7 days 18 years no limit Both history of sensitivity to vancomycin BMI≥30 vancomycin-resistant microorganism in the antibiogram Pregnancy, breastfeeding under hemodialysis, peritonealdialysis, or CCRT Patients who have had effective antibiotic therapy with an effective dose and treatment period during the last 48 hours are excluded from the study unless Have evidence of previous antibiotic treatment failure, or antibiotic resistance to previous cases. Patients who are treated with antibiotics for other reasons Patients who are treated with topical antibiotic on diabetic foot ulcer Receiving vancomycin for surgical prophylaxis E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Forty drug candidate patients receiving Laoding dose with a dose (20-35 mg/kg) of 25 mg/kg vancomycin (vancomycin injection vial of Dena Pharmaceutical Company) (maximum 2 grams, even in patients with a weight of more than 80 kg, a loading dose of more than 2 grams was given (can't) infusion within 2 hours and then receiving a maintenance dose (15-20 mg/kg/dose every 8 to 12 hours) in the amount of 500 to 2000 mg (for every 500 mg of vancomycin, infusion should be done for 30 minutes) Based on the GFR calculated from the Cockrauf-Gault formula, Control group: forty drug candidate patients without receiving the loading dose of vancomycin (without receiving the loading dose) received maintenance doses of vancomycin (Vancomycin injection vial of Dana Pharmaceutical Company) with a dose of 15-20 mg/kg/dose every 8 to 12 hours (calculated based on GFR from the Cockrauf-Gault formula) and the infusion rate should be 30 minutes per 500 mg of vancomycin. Comparison of clinical outcomes in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study for up to 7 days. Method of measurement: Examination of clinical outcome based on clinical manifestations. Comparison of laboratory results in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study up to 7 days. Method of measurement: Examining laboratory results based on inflammatory factors, Erythrocyte Sedimentation rate and C-reactive protein and white blood cell count. Comparison of the occurrence of acute kidney injury in patients with diabetic foot infection in two groups receiving vancomycin loading dose and the group not receiving it. Timepoint: At the beginning of the study and during the study up to 7 days. Method of measurement: Assessment of acute kidney injury based on serum creatinine and urine volume. Yazd University of Medical Sciences Approved 2024-03-13 Faculty of Medicine, Shahid Sadougi University of Medical Sciences, Yazd central organization of Shahid Sadoughi university of medical science, Shahid Bahonar square, Yazd Town Yazd Yazd Iran (Islamic Republic of)