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

A phase 3, randomized, double-blind, placebo-controlled, parallel-group clinical trial of 70 patients. Eligible patients are allocated to the drug or placebo group by blocked randomization.

Setting: Intensive care units of Kosar Hospital affiliated to Semnan University of Medical Sciences and Namazi Hospital affiliated to Shiraz University of Medical Sciences. Intervention: Patients who receive vancomycin for any indication and meet the inclusion criteria, will be randomly assigned to drug or control group. The drug group will receive curcumin tablet (500 mg three times a day) and control group will receive placebo (one tablet three times a day) for 7 days started concurrently with vancomycin. Effect of intervention on renal function and urine output will be evaluated. Patient and the researcher who measures the study outcomes will be blinded until the completion of the study and the detection of its codes.

Patients aged 18-65; receiving vancomycin for at least 7 days; creatinine clearance > 45 ml/min; not having proteinuria and/or hematuria, acute kidney injury or any underlying renal disorder, septic shock, sever liver disease, and sever and active bleeding; not using any other nephrotoxic drug; not using antioxidant supplements; not receiving anticoagulant drugs at therapeutic doses or warfarin

Patients in drug group will receive curcumin tablet (ِDineh Iran Company), 500 mg three times a day for 7 days. Patients in control group will receive placebo (ِDineh Iran Company) for 7 days.

Serum Creatinine; Blood Urea Nitrogen; Creatinine Clearance; 24-hour Urine Output; The Number of Cases of Acute Kidney Injury; SOFA Score

It was changed to a two-centered study.

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.

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.

Confidential