Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSergey Savko

About this trial

modern medicine, associated with profound morbidity and high mortality rates. As a clinical syndrome characterized by a dysregulated systemic response to infection, its progression toward life-threatening organ dysfunction is driven by an array of signaling molecules. Extracorporeal therapy has emerged as a key adjunctive strategy for the targeted elimination of these inflammatory mediators. While current modalities - including non-selective cytokine adsorption, selective LPS-adsorption, and therapeutic plasma exchange (TPE) - have shown clinical benefits in specific patient cohorts, research into more precise interventions continues.

A new frontier focuses on the extracorporeal removal of cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs), which recognized as pivotal drivers of systemic inflammation. This study evaluates the "Nucleocor" plasma adsorption column, a pioneering device designed for the selective removal of DNA-containing structures. By targeting septic shock patients with prognostically unfavorable cfDNA elevations, this research aims to establish standardized protocols and generate the evidence base necessary for integrating this novel therapy into national clinical guidelines.

Eligibility criteria

Qualifiers

The age of patients is 18-65 years,

Septic shock (Sepsis-3 criteria) with dependence on vasopressor and/ or sympathomimetic therapy (norepinephrine - more than 0.05 mcg / kg/min, adrenaline - more than 0.05 mcg / kg/min), persisting after correction of hypovolemia.

concentration of cfDNA in the bloodstream is greater than its prognostically unfavorable level, determined by the fluorimetric method, or the presence of predictors of a prognostically unfavorable level of cfDNA: the concentration of mixed venous blood lactate is more than 1.9 mmol/l, the number of SOFA scores is more than 7

Disqualifiers

Clinical death after the onset of sepsis;

An untreated surgical infection site;

History of transfusion-related acute lung injury;

Allergy to heparin, GIT in the anamnesis;

Trial design

Treatments tested in this trial

  • Extracorporeal therapy
  • Extracorporeal elimination of cfDNA using "Nucleocore"

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sergey Savko

Lead sponsor

City clinical hospital named after S. S. Yudin, Moscow City Health

Sponsor institution