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NCT07711197
Effects of Hemoadsorption on Vascular Integrity in Septic Shock
Conditions: Septic Shock
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Semmelweis University
Location: Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika). Budapest
Summary
This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.
Eligibility Criteria
Inclusion Criteria:
* Septic shock as defined by Sepsis-3 criteria.
* Serum lactate levels \>2 and \ 0.5 µg/kg/min.
* Systemic corticosteroid treatment on board for at least 30 minutes.
* Tissue perfusion impairment: Persistently elevated serum lactate AND/OR prolonged capillary refill time (\> 3 seconds) despite standard therapy.
* Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).
* Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.
* Inclusion within a maximum of 12 hours after the onset of vasopressor need.
* High likelihood of a dysregulated immune response (PCT ≥ 5 ng/mL AND/OR IL-6 ≥ 1000 pg/mL AND/OR Ferritin ≥ 1000 ng/mL).
* Written informed, retrospective or prospective consent.
Exclusion Criteria:
* Patients under 18 years of age and over 80.
* Unlikely to survive for 24 hours (Moribund).
* Pregnancy.
* SOFA-2 score ≥ 16 at ICU admission.
* Source control is uncertain.
* Thrombocytopenia (\
Source: ClinicalTrials.gov (NCT07711197). StuddyBuddy aggregates publicly available trial information.