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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT04910893
Eligibility Criteria:
Inclusion Criteria:
Patients diagnosed septic shock in the 24 hours ensuing diagnosis:
(I) severe, refractory septic shock defined as:
1. an acute SOFA score increase ≥2 points consequent to a presumed or proven infection
2. volume resuscitation of at least 30ml/kg in the last 24 hours
3. a Vasopressor Dependency Index11 (VPI) above or equal to 3
4. a persistently elevated serum lactate level \>2mmol/l (II) Interleukin-6 levels equal or above 1000 ng/l (III) were above 18 years of age.
Exclusion Criteria:
1. Contraindication on ethical grounds
2. child bearing or breastfeeding women
3. terminal patients
4. human immunodeficiency virus with a CD4 cell count \<0.2 106/l
5. allergy to Polystyrene/ Divinylbenzene, Polycarbonate, Polypropylene, Silicon or Polyester
6. need for extra-corporeal membrane oxygenation
7. no given consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04910893
Study Brief:
Protocol Section:
NCT04910893