Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

Sponsor
Sergey Savko
Study ID
NCT07657767
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Extracorporeal therapy — DEVICE
    Extracorporeal therapy - only in case of AKI - in HD/CVVHD format using standard polysulfone filters with a permeability of no more than 30 kDa
  • Extracorporeal elimination of cfDNA using "Nucleocore" — DEVICE
    Device: "Nucleocore" (NPO "Pokcard") Extracorporeal cfDNA elimination will be performed according to the following protocol. Vascular access is established by inserting a 12 Fr, 200 mm catheter into the femoral vein. The procedures are conducted using the Spectra Optia system ("Exchange Set") with the following parameters: blood flow rate of 70-100 mL/min, plasma flow rate of 40-50 mL/min, and citrate anticoagulation (using a 4% sodium citrate solution) with an anticoagulant ratio of 1:20, in accordance with the Terumo "Plasmapheresis" procedure protocol. Monitoring of the patient's venous blood electrolytes and pH is performed hourly; hypocalcemia is managed via continuous infusion of a 10% calcium gluconate solution. Adsorption procedures for DNA-containing structures will be performed daily over two consecutive days, processing two total plasma volumes per session.

Study Details

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 Dates

First listed
Jun 18, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Baseline therapy
    Baseline therapy Patients of group one received standard treatment according to Surviving Sepsis, according to the Clinical recommendations of the Ministry of Health of the Russian Federation - Sepsis (in adults)
  • Other: Baseline therapy + Extracorporeal elimination of cfDNA
    Baseline therapy \+ Extracorporeal elimination of cfDNA using "Nucleocore" (NPO "Pokcard")

Primary Outcome Measure

cfDNA following the completion of extracorporeal therapy [ Time Frame: at baseline and 72 hours post-hemosorption ]

Central Contacts

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