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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT02052895
Eligibility Criteria:
Sepsis/SIRS Patients
Inclusion Criteria:
* Male or female aged ≥ 21 years
* Appropriate clinical data to enable classification into sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
Exclusion Criteria:
* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
Control
Inclusion Criteria:
* Male or female aged ≥ 21 years
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
Exclusion Criteria:
* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
End Stage Renal Disease
Inclusion Criteria:
* Male or female aged ≥ 21 years
* Documented diagnosis of end stage renal disease currently undergoing dialysis
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
Exclusion Criteria:
* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02052895
Study Brief:
Protocol Section:
NCT02052895