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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT04289506
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria for community-acquired Sepsis and Septic Shock
1. Age =\> 18
2. Admission to hospital within 72 hours of symptoms onset and development of clinical signs of sepsis
3. Diagnosis of sepsis
* SEPSIS is defined as a (1) DEFINED FOCUS OF INFECTION AND (2) SOFA\>2, with at least ONE organ specific SOFA subscore =2.
1. (1) DEFINED FOCUS OF INFECTION is indicated by either i. An organism grown in blood or sterile site OR ii. An abscess or infected tissue (e.g. pneumonia, peritonitis, urinary tract, vascular line infection, soft tissue, etc).
2. (2) The SOFA score criteria are described in the Appendix \[7\]
* SEPTIC SHOCK is defined as SEPSIS plus the presence of hypotension requiring the use of vasopressors to maintain mean arterial pressure of 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L persisting after adequate fluid resuscitation \[8\]
Inclusion Criteria for Critically Ill patients without infection
1. Patients admitted to the ICU following out-of hospital cardiac arrest OR Patients admitted to the ICU following major trauma (ISS\>12) OR Patients admitted to the ICU following pancreatitis
2. Have multiorgan failure as defined by SOFA\>2, with at least ONE organ specific SOFA subscore =2.
3. Patients must not be receiving antibiotics for treatment of known or suspected infection
4. patient already has or will require arterial cannulation as part of standard treatment
Exclusion Criteria:
* 1\. Patients who are on immune-modulating therapy (e.g., methotrexate, prednisolone \>5mg/day, or other immunosuppressants) for any length of time within 6 months of index admission 2. Patients with acquired cellular immune deficiency (E.g. active HIV infection or AIDS); 3. Patients with concurrent blood-borne viral infections (E.g. Hepatitis B or C) 4. Patients with any haematological malignancy in their past medical history; 5. Patients who are on chronic haemodialysis; 6. Solid organ transplant recipients; 7. Patients who have biopsy, image or endoscopy proven liver cirrhosis; 8. Patients who are not expected to survive beyond 90 days due to the advancement of their underlying disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04289506
Study Brief:
Protocol Section:
NCT04289506