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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT03422159
Eligibility Criteria:
Inclusion Criteria:
i. Diagnosis of sepsis or septic shock within 12 hours of admission to the ICU ii. Informed consent as dictated by IRB and local practice. iii. Compliance with the 3 hour sepsis bundle
* 30ml/kg of intravenous crystalloid fluid (e.g.: sodium chloride 0.9%) for lactic acid \>4 and/or systolic blood pressure \<90mmHg / mean arterial pressure \<65mmHg
* Lactic acid level drawn
* Broad spectrum antibiotics given after obtaining blood cultures
Exclusion Criteria:
i. Age \< 18 years ii. Pregnant iii. DNR/DNI with limitations of care on admission iv. Patients with terminal end stage disease (i.e. stage IV cancer, end stage heart failure) that are unlikely to survive to hospital discharge v. Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma \[64-66\] vi. Requirement for immediate surgery \[64-66\] vii. Patients with HIV and a CD4 \< 50 mm2 \[64-66\] viii. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.\[39\] ix. Patients with sepsis/septic shock transferred from another hospital x. Patients with features of sepsis/septic shock \> 24 hours after admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03422159
Study Brief:
Protocol Section:
NCT03422159