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IRCT20230814059148N1 IRCT 2023-10-10 Tabriz University of Medical Sciences the effect of febuxostat in sepsis Evaluating the effect of febuxostat drug administration compared to placebo in septic patients hospitalized in the intensive care unit 2023-11-22 anticipated 40 Complete https://irct.ir/trial/72053 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: So far, this drug has not been used in septic patients with this therapeutic purpose and effectiveness, and the results of its clinical trial have not been found in the search for sources. The study was designed based on published animal studies, Randomization description: 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, Blinding description: 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. 3 sepsis. Intervention 1: Intervention group: Receive 80 mg febuxostat tablets for 10 days, one tablet daily. Intervention 2: Control group: placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Currently, no decision has been made in this regard and therefore there is no plan for it. This form will be updated after consultation with the Professor in charge of conducting this trial as well as the practical progress of the process.
public Saman Chaparzade
No. 142, Aramis Block, Setare El-Goli tower, Golshahr sqare , El-Goli road, Tabriz
Tabriz Iran (Islamic Republic of) 5168668999 +98 41 3382 8154 chaparzade.sam@gmail.com Tabriz University of Medical Sciences scientific Saman Chaparzade
No. 142, Aramis Block, Setare El-Goli tower, Golshahr sqare , El-Goli road, Tabriz
Tabriz Iran (Islamic Republic of) 5168668999 +98 41 3382 8154 chaparzade.sam@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Septic patients who are hospitalized in the intensive care unit 18 years 80 years Both Patients taking Azathioprine, Mercaptopurine, or Methotrexate at the same time Patients with sensitivity to Febuxostat or Allopurinol or Lactose or any component of the formulation of these drugs Patients with severe liver failure class C (ALT >3×ULN and total serum bilirubin more than 2×ULN) Patients with malignancy Pregnant and lactating women Treatment - Drugs Placebo Intervention group: Receive 80 mg febuxostat tablets for 10 days, one tablet daily Control group: placebo Interleukin 6 (IL-6) plasma level. Timepoint: Day 0 (before the start) and day 4 of the study. Method of measurement: ELISA kit for detection of interleukin 6 serum level. The state of organ failure in sepsis. Timepoint: Days 0, 3, 7, 10. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score. Tabriz University of Medical Sciences Approved 2023-08-13 Ethics Committee of Tabriz University of Medical Sciences - Faculty of Pharmacy Presidency, Department of Clinical Pharmacy, Faculty of Pharmacy, Campus of Tabriz University of Medical Sciences, Atar Nishaburi North, Golgasht avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)