Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

Starting soon · Not applicable

Conditions studied: Sepsis

In brief

Sepsis continues to be a major global health concern, characterized by high morbidity and 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 lipopolysaccharides 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 are 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.

Key facts

Study ID

NCT07657767

Run by

Sergey Savko

People needed

60

Starts

2026-07-10

Expected to finish

2027-02-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;
• Uncontrolled bleeding or a high risk of its occurrence,
• The presence of cardiovascular events within the last 2 months: AMI, stroke, PE, Severe congestive CHF;
• Severe chronic congestive heart failure;
• End-stage CKD;
• Chronic use of immunosuppressive therapy;
• HIV infection, Constant use of immunosuppressive therapy, severe granulocytopenia (WBC less than 500 cells /mm3),
• Development of acute cardiovascular insufficiency characterized by hypotension (BP system. less than 60 mmHg) and/or bradycardia (heart rate less than 40 min -1), refractory to adrenaline (bolus of more than 100 micrograms or infusion of more than 300 mcg/kg/min).

Where it is running

• Moscow City Clinical Hospital named after S. S. Yudin — Moscow, Russia

Full record on ClinicalTrials.gov

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