Effects of Hemoadsorption on Vascular Integrity in Septic Shock
Starting soon · Not applicable
Conditions studied: Septic Shock
In brief
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.
Key facts
- Study ID
- NCT07711197
- Run by
- Semmelweis University
- People needed
- 110
- Starts
- 2026-09-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Septic shock as defined by Sepsis-3 criteria.
- Serum lactate levels >2 and <8 mmol/L at screening.
- Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
- Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose > 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.
You may not qualify if…
- 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 (<20,000/µL).
- Criteria of standard guideline-based medical treatment not exhausted.
- End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2), chronic liver failure (MELD Score >30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).
- Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).
Where it is running
- Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika). — Budapest, Hungary
Full record on ClinicalTrials.gov
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