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IRCT20240501061620N1 IRCT 2024-05-08 Semnan University of Medical Sciences Evaluation of the effect of curcumin in the prevention of vancomycin-induced nephrotoxicity in patients hospitalized in the intensive care unit Evaluation of the effect of curcumin in the prevention of vancomycin-induced nephrotoxicity in patients hospitalized in the intensive care unit 2024-06-04 anticipated 40 Complete https://irct.ir/trial/76622 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization of samples will be based on the blocked randomization method. Information such as the number of treatment groups (the two main intervention groups, drug for example, A and placebo, for example, B), the size of the blocks (a multiple of the number of groups that will be selected, in this study the size of the blocks will be 4) and the total number of patients (the sample size of 40 people) will be entered into the Internet software for this calculation (for example, available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes with the final analysis is obtained, a code is assigned to each patient who enters the study, and the type of group that should take medication or placebo will be determined, Blinding description: After preparation of curcumin tablets and placebo (similar to the curcumin tablet in terms of size and color), drug or placebo will be delivered in the same packaging containers by the main executor of the project who is not involved in the sampling, and the relevant code is written in each container. Patient and the researcher who measuring the study outcomes are blind to the distribution of patients in the curcumin and placebo groups until the completion of the study and the detection of its codes. 3 Acute kidney failure. Intervention 1: Intervention group: Patients will receive curcumin tablet (Dineh Iran Company), 500 mg three times a day for 7 days. Intervention 2: Control group: Patients will receive placebo tablet (Dineh Iran Company) for 7 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidential
public Solaleh Rezanavaz Gheshlagh
Kosar Hospital, Golestan Town, Basij Blvd
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 0000 solaleh.rezanavaz2017@gmail.com Semnan University of Medical Sciences scientific Bahareh Hakiminia
School of Pharmacy, Golestan Town, Basij Blvd
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3344 1740 baharehhakiminia@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 18-65, receiving vancomycin Creatinine clearance > 45 ml/min 18 years 65 years Both Proteinuria and/or hematuria, acute kidney injury or any underlying renal disorder Septic shock Sever liver disease Sever and active bleeding Receiving any other nephrotoxic drug Receiving anticoagulant drugs at therapeutic doses or receiving warfarin Receiving antioxidant supplements N17.9 Acute kidney failure, unspecified Prevention Placebo Intervention group: Patients will receive curcumin tablet (Dineh Iran Company), 500 mg three times a day for 7 days. Control group: Patients will receive placebo tablet (Dineh Iran Company) for 7 days. Serum Creatinine. Timepoint: At baseline and 2, 4, 6, and 8 days after initiation of intervention. Method of measurement: Spectrophotometry. Blood Urea Nitrogen. Timepoint: At baseline and 2, 4, 6, and 8 days after initiation of intervention. Method of measurement: Spectrophotometry. Creatinine Clearance. Timepoint: At baseline and 2, 4, 6, and 8 days after initiation of intervention. Method of measurement: Modification of Diet in Renal Disease (MDRD) Formula. 24-hour Urine Output. Timepoint: Days 1 to 7. Method of measurement: Urine bag. The number of patients with acute kidney injury. Timepoint: End of intervention. Method of measurement: Counting. Sequential Organ Failure Assessment (SOFA). Timepoint: At baseline and end of intervention. Method of measurement: SOFA table. Mortality rate of patients. Timepoint: After intervention until discharge from ICU. Method of measurement: Counting. Length of stay in the ICU. Timepoint: At discharge day from ICU. Method of measurement: Counting. Semnan University of Medical Sciences Approved 2024-03-11 Ethics Committee of Semnan University of Medical Sciences Headquarter of Semnan University of Medical Sciences and Health Services, Basij Blvd Semnan Semnan Iran (Islamic Republic of) Approved 2024-03-11 Ethics Committee of Shiraz University of Medical Sciences Headquarter of Shiraz University of Medical Sciences and Health Services, Zand Ave Shiraz Fars Iran (Islamic Republic of)