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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT02276066
Eligibility Criteria:
Inclusion Criteria:
* Presence in the surgery or trauma ICU
* Age of ≥18 years
* Entrance into our sepsis protocol
* Ability to obtain informed consent.
Exclusion Criteria:
* Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. recurrent, advanced or metastatic cancer)
* Severe traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8)
* Refractory shock (i.e., patients who die within 12 hours)
* Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
* Patient or patient's family are not committed to aggressive management of the patient's condition and/or the patient has a DNR/DNI on file.
* Severe CHF (NY Heart Association Class IV)
* Child-Pugh C liver disease or pre-liver transplant.
* Known HIV infection with CD4 count \<200 cells/mm3
* Organ transplant recipient on immunosuppressive agents
* Known pregnancy and mother's that are breastfeeding
* Prisoners
* Institutionalized patients
* Inability to obtain informed consent.
* Chemotherapy or radiotherapy within 30 days prior to sepsis.
* End stage renal disease on admission.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02276066
Study Brief:
Protocol Section:
NCT02276066