Not Yet RecruitingNot Applicable

Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

Russia60 participantsStarted 2026-07-10

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses an extracorporeal device to physically remove cell-free DNA from the blood during septic shock — how does that approach compare to the standard treatments my loved one is already receiving in the ICU, and could both happen at the same time?
2Since this trial hasn't started recruiting yet, what is the realistic timeline before it would be available, and is that relevant given how urgent septic shock treatment needs to be?
3The trial is listed as 'Phase NA,' which suggests it may be a device or procedure study rather than a drug trial — what does that mean for how much safety and effectiveness data already exists for this type of extracorporeal cfDNA removal?
4One of the main things being measured is time to resolution of septic shock — what does 'resolution' mean in practice, and how does the expected timeline in this trial compare to what my loved one might experience with current standard care?
5Given that this trial is not yet recruiting, are there any similar trials or existing treatments targeting cell-free DNA or the underlying inflammation in septic shock that my loved one could potentially access right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cfDNA following the completion of extracorporeal therapy

Timeframe: at baseline and 72 hours post-hemosorption

Rate of septic shock resolution by Day 7

Timeframe: Up to Day 7

Trial details

NCT IDNCT07657767

SponsorSergey Savko

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Sergey Savko

89635156233 d.t.d.savko@gmail.com

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