Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

NCT07657767 | Not Yet Recruiting

• 1 other identifier: № 0910-4/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Keywords

Sepsis; Extracorporeal therapy; cfDNA; Non-selective hemoperfusion

Outcome Measures

Primary Outcomes (2)

• cfDNA following the completion of extracorporeal therapy

  Circulating cell-free DNA (cfDNA) levels in septic shock, measured via a fluorometric method (cobas® cfDNA Sample Preparation Kit), which enables the quantification of chromatin-containing molecular structures in the bloodstream

  at baseline and 72 hours post-hemosorption

• Rate of septic shock resolution by Day 7

  The percentage of participants presenting with successful cessation of all vasopressor support (norepinephrine) maintained for at least 24 consecutive hours without recurrence of shock, evaluated up to day 7.

  Up to Day 7

Secondary Outcomes (13)

• 28-day mortality rate

  Day 28

• Duration of ICU stay

  Up to 28 days (or through hospital discharge)

• Number of ventilator-free days

  Up to 28 days

• Number of renal replacement therapy (RRT)-free days

  Up to 28 days

• SOFA score

  at baseline, 24, 48, and 72 hours post-hemosorption

Study Arms (2)

Baseline therapy

OTHER

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)

Device: Extracorporeal therapy

Baseline therapy + Extracorporeal elimination of cfDNA

OTHER

Baseline therapy \+ Extracorporeal elimination of cfDNA using "Nucleocore" (NPO "Pokcard")

Device: Extracorporeal therapy; Device: Extracorporeal elimination of cfDNA using "Nucleocore"

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

Baseline therapy; Baseline therapy + Extracorporeal elimination of cfDNA

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.

Baseline therapy + Extracorporeal elimination of cfDNA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Sergey Savko: lead

Study Sites (1)

Moscow City Clinical Hospital named after S. S. Yudin

Moscow, Russia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sergey Savko

CONTACT

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

Nikolai Krotenko, Cand. of Sci. (Med.)

CONTACT

npkrotenko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Physician, Intensive Care Unit, S.S. Yudin City Clinical Hospital, Moscow, Russia

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

RU (1)