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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT05044403
Eligibility Criteria:
Inclusion Criteria:
* Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
* Sepsis of abdominal origin with controlled infectious focus.
* Noradrenaline dose\> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
* Dysfunction of two or more organs with SOFA ≥ 9 (5).
* Blood lactate ≥ 2 mmol / L.
* Procalcitonin (PCT)\> 10 ng / mL.
* CRP\> 100 mg / L.
* IL-6\> 2000 pg / ml.
Exclusion Criteria:
* Age under 18 years or over 80 years.
* Pregnancy or breastfeeding.
* Terminally ill patients or with a life expectancy of less than 48 hours.
* Thrombocytopenia \<60,000 / mm3.
* Pancytopenia.
* Severe coagulopathy with high risk of bleeding.
* Inclusion in another research protocol.
* In case of re-entry during the study period, only the first admission will be included.
* Use of another haemoperfusion device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05044403
Study Brief:
Protocol Section:
NCT05044403