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IRCT20120215009014N500 IRCT 2024-02-29 Hamedan University of Medical Sciences Effect of MitoQ versus placebo on serum the level of oxidative stress biomarkers in patients with early septic shock Effect of MitoQ versus placebo on serum the level of oxidative stress biomarkers in patients with early septic shock: a double-blind randomized clinical trial 2024-04-03 anticipated 40 Complete https://irct.ir/trial/75681 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached, Blinding description: Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study. 3 Early septic shock. Intervention 1: Intervention group: Routine treatment with MitoQ capsules 20 mg every 12 hours for 5 days. Intervention 2: Control group: Routine treatment plus placebo capsules every 12 hours for 5 days. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Hanieh Hasani Pajoo
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 hasani.h.79@gmail.com Hamedan University of Medical Sciences scientific Dr. Maryam Mehrpooya
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 m_mehrpooya2003@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Premature septic shock Receive vasopressor for at least 6 and maximum for 24 hours 18 years 65 years Both Pregnancy or breastfeeding Treated with other antioxidant and anti-inflammatory drugs Chronic liver or kidney disease R65.21 Severe sepsis with septic shock Treatment - Drugs Placebo Intervention group: Routine treatment with MitoQ capsules 20 mg every 12 hours for 5 days Control group: Routine treatment plus placebo capsules every 12 hours for 5 days The serum level of catalase enzyme. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By Catalase Activity Assay (CAA). Serum level of glutathione peroxidase enzyme. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By the Glutathione Peroxidase (GPx) Activity Assay. Serum level of total antioxidant capacity. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By the Total Antioxidant Capacity (TAC) Assay. Malonaldehyde serum level. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By the Oxygen Radical Absorbance Capacity (ORAC) assay. Serum levels of thiol groups. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By the Ellman's assay. Serum levels of iron and ferritin. Timepoint: Before the intervention and on the third and fifth days after the intervention. Method of measurement: By the Total Iron-Binding Capacity (TIBC) Measurement and the enzyme-linked immunosorbent assay (ELISA). Hamedan University of Medical Sciences Approved 2024-02-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)