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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT06613256
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteer
* Adult ≥ 18 years
* Able and willing to give consent
Surgical patients
* Adult ≥ 18 years
* Patients admitted to RSFT for planned major surgery
Critically ill patients
* Adult ≥ 18 years
* Emergency admission to ICU at RSFT
* Meets the sepsis 3.0 definition
Exclusion Criteria:
Healthy volunteer
* Not currently a patient within the hospital
* Absence of inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes, cardiovascular disease and CKD.
* Not on immunomodulatory medications, such as corticosteroids
* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)
Surgical patients
* Patients with restricted liberty, prisoners or under legal protection
* Anticipated prohibitively difficult venous cannulation
* Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, sepsis, diabetes with end organ damage, cardiovascular disease and CKD
* Currently prescribed immunomodulatory medication or immunocompromised
* Received chemotherapy within 2 weeks of predicted sampling
* Receiving vasopressor support prior to surgery
* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)
Critically ill patients
* Patients with restricted liberty, prisoners or under legal protection• Anticipated prohibitively difficult venous cannulation
* Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes with end organ damage, cardiovascular disease and CKD.
* Currently prescribed immunomodulatory medication or immunocompromised
* Received chemotherapy within 2 weeks of predicted sampling.
* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06613256
Study Brief:
Protocol Section:
NCT06613256