Effects of Hemoadsorption on Vascular Integrity in Septic Shock
ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSemmelweis University
About this trial
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
Qualifiers
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.
Disqualifiers
Patients under 18 years of age and over 80.
Unlikely to survive for 24 hours (Moribund).
Pregnancy.
SOFA-2 score ≥ 16 at ICU admission.
Trial design
Treatments tested in this trial
- CytoSorb hemoadsorption
- Standard Medical Therapy (SMT)
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Semmelweis University
Lead sponsor
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
Collaborator
Source ClinicalTrials.gov