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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT03334227
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 yr. with diagnostic criteria for severe sepsis, within 12 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate \> 4, or persistence of organ dysfunction (oliguria \< 0.5 ml/kg/h, cyanosis, or altered consciousness).(qSOFA 1, 2 or 3)
Exclusion Criteria:
* Patients who require immediate ventilatory support both invasive and non-invasive, defined by severe hypoxemia (PaO2/FiO2 \< 150), severe tachypnea (40 x') with signs of respiratory fatigue or low level of consciousness (Glasgow \< 8).
* Patients with limitation of the therapeutic effort or orders of not CPR.
* Patients not susceptible to treatment with HFNC (facial trauma, tracheostomized, rejection of previous treatments with HFNC).
* Participation in other clinical trials that may affect survival.
* Home treatment with oxygen, CPAP or Non-invasive ventilation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03334227
Study Brief:
Protocol Section:
NCT03334227