Effect of MitoQ versus placebo on clinical outcomes in patients with early septic shock: a double-blind randomized clinical trial

To assess the effect of MitoQ versus placebo on clinical outcomes in patients with early septic shock

This is a Phase III double-blind randomized clinical trial with a parallel control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Besat Hospital in Hamadan city, involving 40 eligible patients with early septic shock. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.

Inclusion criteria: Age 18 to 65 years Premature septic shock Receive vasopressor for at least 6 and maximum for 24 hours Exclusion criteria: Pregnancy or breastfeeding Treated with other antioxidant and anti-inflammatory drugs Chronic liver or kidney disease

Intervention group: Routine treatment with MitoQ capsules 10 mg every daily for 5 days Control group: Routine treatment plus placebo capsules daily for 5 days

Mortality rate, the number of patients under the mechanical ventilation, the number of days treated with mechanical ventilation, the number of patients needing vasopressor treatment, the number of days treated with vasopressors, the amount of vasopressor dose, changes in Sequential Organ Failure Assessment (SOFA), serum lactate level, CRP serum level, the need for kidney replacement therapy, the length of hospitalization in the intensive care unit and hospital

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.

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.