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Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

NCT07657767 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Extracorporeal therapy

Extracorporeal therapy - only in case of AKI - in HD/CVVHD format using standard polysulfone filters with a permeability of no more than 30 kDa

DEVICE

Extracorporeal elimination of cfDNA using "Nucleocore"

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.

Sponsors & Collaborators

  • Sergey Savko

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2026-12-01
Completion
2027-02-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657767 on ClinicalTrials.gov