Effect of MitoQ versus placebo on clinical outcomes in patients with early septic shock

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N499

Enrollment

Registered

2024-02-29

Start date

2024-04-05

Completion date

Unknown

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early septic shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: Routine treatment with MitoQ capsules 10 mg every daily for 5 days. Intervention 2: Control group: Routine treatment plus placebo capsules daily for 5 days.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years Premature septic shock Receive vasopressor for at least 6 and maximum for 24 hours

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Treated with other antioxidant and anti-inflammatory drugs Chronic liver or kidney disease

Design outcomes

Primary

Measure	Time frame
Mortality rate. Timepoint: During the 28 days after intervention. Method of measurement: Based on medical records.;The number of patients under the mechanical ventilation. Timepoint: during the 28 days after the intervention. Method of measurement: Based on the medical record.;The number of days treated with mechanical ventilation. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The number of patients needing vasopressor treatment. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical records.;The number of days treated with vasopressors. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The amount of vasopressor dose. Timepoint: During 5 days after the intervention. Method of measurement: Based on the medical record.;Changes in Sequential Organ Failure Assessment (SOFA). Timepoint: During 5 days after intervention. Method of measurement: Based on medical records.;Serum lactate level. Timepoint: During 5 days after intervention. Method of measurement: By laboratory method.;CRP serum level. Timepoint: During 5 days after the intervention. Method of measurement: by laboratory method.;The need for kidney replacement therapy is all. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The length of hospitalization in the intensive care unit and hospital. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.	—

Measure

Time frame

Mortality rate. Timepoint: During the 28 days after intervention. Method of measurement: Based on medical records.;The number of patients under the mechanical ventilation. Timepoint: during the 28 days after the intervention. Method of measurement: Based on the medical record.;The number of days treated with mechanical ventilation. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The number of patients needing vasopressor treatment. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical records.;The number of days treated with vasopressors. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The amount of vasopressor dose. Timepoint: During 5 days after the intervention. Method of measurement: Based on the medical record.;Changes in Sequential Organ Failure Assessment (SOFA). Timepoint: During 5 days after intervention. Method of measurement: Based on medical records.;Serum lactate level. Timepoint: During 5 days after intervention. Method of measurement: By laboratory method.;CRP serum level. Timepoint: During 5 days after the intervention. Method of measurement: by laboratory method.;The need for kidney replacement therapy is all. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.;The length of hospitalization in the intensive care unit and hospital. Timepoint: During the 28 days after the intervention. Method of measurement: Based on the medical record.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadis Moradbaki

Hamedan University of Medical Sciences

hadismoradbaki@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026