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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT05011656
Eligibility Criteria:
Inclusion Criteria:
1. Admitted to an ICU with pathogen associated shock defined as:
* The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation, AND
* Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
2. Male or non-pregnant female adult
3. At least 18 years of age at time of enrollment
Exclusion Criteria:
1. Pregnant or breast feeding
2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason
3. Not anticipated to survive more than 24 hours
4. Known allergy to heparin sodium
5. Patients who cannot tolerate placement of double-lumen catheter
6. High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT)
7. Inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors)
8. Advanced cancer (defined as stage IV) with life expectancy of less than 30 days
9. Unable to obtain informed consent from either patient or legally authorized representative (LAR)
10. Hypotension and volume depletion due to etiologies other than sepsis.
11. Neutropenia with an absolute neutrophil count \<500mm3
12. Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study.
13. If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation".
14. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee.
15. Advanced directive for "Do Not Resuscitate".
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05011656
Study Brief:
Protocol Section:
NCT05011656