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:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT04134403
Eligibility Criteria:
Inclusion Criteria:
* Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
* SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
* Vasopressor required to maintain MAP ≥ 65 AND
* Serum lactate level \>2.0 mmol/L
* Age ≥ 18 years
* Non-pregnant
* Ability to consent with medical capacity or legally authorized representative (LAR) consent
Exclusion Criteria:
* Age \< 18 years
* Pregnant defined by negative serum HCG in all females
* Patients with limitation of care (i.e. DNR)
* Known G6PD deficiency
* Excluding primary admission diagnosis including the following:
* Acute stroke
* Acute coronary syndrome
* Active gastrointestinal bleed
* Burn
* Trauma
* Prisoners
* \>1 episode of sepsis in hospital admission
* Vasopressor use prior to randomization for more than 24 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04134403
Study Brief:
Protocol Section:
NCT04134403