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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT02330432
Eligibility Criteria:
Inclusion Criteria:
Patients with severe sepsis within 48 hours of first organ dysfunction
* Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \>90 and \>65 mm Hg, respectively
* Renal dysfunction: urine output \<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation
* Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis
* Hematologic dysfunction: platelet count \<100,000/mm3 or decrease by 50% in the three days preceding enrollment
* Unexplained metabolic acidosis: pH ≤7.30
Exclusion Criteria:
* Pregnancy
* Gram-positive culture
* Only fungal infection as source of sepsis
* Patients who received cardiopulmonary resuscitation
* Those on immunosuppressive therapy
* Those unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02330432
Study Brief:
Protocol Section:
NCT02330432