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 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT02127502
Eligibility Criteria:
Inclusion Criteria:
1. 18-89 years old on the day of ICU admission
2. SIRS present as defined by the presence of two or more of the following:
* Temperature \> 38°C or \< 36°C
* Heart Rate \> 90 beat/min
* Tachypnea \> 20/min or PaCO2 \< 32 mmHg
* White Blood Cell count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)
Exclusion Criteria:
1. Consent not provided
2. Age less than 18 or greater than 89 years old on the day of ICU admission
3. Not admitted to ICU
4. Clinical cultures or serologies not obtained
5. Subject has been admitted to study hospital (or transferring facility) for ≥ 24 hours
6. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours.
7. Patients on non-prophylactic antibiotics for more than 24 hours prior to ICU admission
8. Delay of \>24 hours between trial enrollment and sample draw time
9. Ethnic/racial category has completed enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT02127502
Study Brief:
Protocol Section:
NCT02127502