Evaluating the effect of febuxostat drug administration compared to placebo in septic patients hospitalized in the intensive care unit

Evaluating the effect of febuxostat compared to placebo in improving inflammatory indices of septic patients hospitalized in the ICU

Clinical trial with a control group, double-blind, randomized, on 40 patients. For randomization, the clinical trial randomization tool of https://ctrandomization.cancer.gov/ was used.

The purpose of this study is to investigate the effects of febuoxstat in patients with sepsis. This randomized controlled clinical trial is conducted as a double-blind and in the form of a pilot study in Tabriz Imam Reza Hospital on 40 participants aged 18 to 80 with sepsis who have filled out the informed consent form. At the beginning of the study, the demographic and clinical information of the patients is evaluated. 40 patients are randomly placed in 2 groups A and B (20 people in each group). Patients in groups A and B are treated with febuxostat 40 mg or placebo for 10 days.

Inclusion criteria: patients aged 18-80 years with a diagnosis of sepsis with CRP Over 50mg/L. Exclusion criteria: pregnancy, breastfeeding, simultaneous use of azathioprine or mercaptopurine or methotrexate, sensitivity to febuxostat or allopurinol, or severe liver failure class C (ALT >3×ULN and serum total bilirubin more than 2×ULN

At the beginning of the study, the demographic and clinical information of the patients is evaluated. 40 patients were randomly assigned to 2 groups A and B (20 people in each group) and were treated with febuxostat 80 mg or its placebo, once a day for 10 days.

Interleukin 6 (IL-6) biomarker as primary outcome of laboratory findings including CRP, billirubin, Cr, BUN, CBC, LFT and SOFA Score, qSOFA score

Applying changes such as the sampling day (from day 3 to day 4) and removing one of the primary variables due to the impossibility of preparing a kit for its measurement.

Block randomization with 2/4/6 blocks Randomization Unit: Individual The sequence of all possible permutations of intervention and control is written in blocks 4 and 6 Randomization tool: Randomization list from Clinical Trial Randomization Tool website and Excel software

The patients, principal investigator (executive student), supervisor, and relevant nurse will be blinded. Help will be taken from another person to prepare the pockets containing medicine or placebo. Only the code for each patient will be written on the envelopes, and the presenters will not see the list of random numbers. The data will be finally analyzed and the decoding of the codes will be the analyst's responsibility.