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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT05052203
Eligibility Criteria:
Inclusion criteria sepsis group:
* Adult patients, aged between 18 and 85 years
* Able to provide informed consent themselves or informed consent can be obtained via next of kin or legal guardian
* Included in Acutelines, where blood sample was drawn upon ED admission
* Satisfy the Sepsis-3 criteria for sepsis (Figure 2), combined with clinical suspicion of infection and/or fever (body temperature \> 38.5°C)
* Survive at 3 months post discharge
* Inclusion criteria control group:Adult patients, aged between 18 and 85 years
* Able to provide informed consent themselves or informed consent can be obtained via next of kin or legal guardian
* Included in Acutelines, where blood sample was drawn upon ED admission
* Non-infectious reason of admission (specifically syncope, electrolyte disturbance, intoxication, gastro-intestinal bleeding)
4.3 Exclusion criteria
The participants should not meet any of the following exclusion criteria:
* Transfer from another hospital
* Emergency room visit in connection with accidental exposure of bodily material to patient ("needle stick injury")
* Visit an emergency room in connection with organ transplantation
* Discharged home without hospital admittance after ED visit
* Unable to give blood
* Immunosuppressive therapies such as corticosteroids (\>10mg) or small molecule immune suppressants within the last three months, or biologicals administered within the last year
* Radiotherapy or systemic chemotherapy within the last three months
* Known pregnancy; the presence of pregnancy will be verified by asking the potential participant
* A hospitalization of more than 21 days
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05052203
Study Brief:
Protocol Section:
NCT05052203