Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT06005558
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥ 18 years and ≤ 65 with septic shock as defined by Sepsis-3 criteria (confirmed infection, requiring vasopressor to maintain a mean arterial blood pressure (MAP) ≥ 65 mmHg, and serum lactate \> 2 mmol/L after adequate fluid resuscitation), and requiring mechanical ventilation.
Exclusion Criteria:
* myocardial infarction or cerebrovascular accident within the last 3 months.
* severe lung , liver or kidney disease (creatinine \>3.5 mg/dL).
* pregnancy.
* glucose 6-phosphate-dehydrogenase deficiency.
* known allergy to MB or food dyes and the use of nitrates within the last 3 days.
* more than 24 hrs since initiation of norepinephrine.
* other causes of shock than sepsis .
* recent intake (4-weeks) of selective serotonin re-uptake inhibitors or MAOi.
* refusal of the patient guardian to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06005558
Study Brief:
Protocol Section:
NCT06005558