Health TrialsbyHealthPanel

Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSergey Savko

About this trial

modern medicine, associated with profound morbidity and high 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 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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: Efferon CT 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Baseline therapyOther 1 intervention
Group B: Baseline therapy + Extracorporeal elimination of cfDNAOther 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
0-7 days
2

time to resolution of septic shock

Number of days to resolve the septic shock. A patient is given a value of 0 if they die before day 7 or are still remains in shock at day

Time frame
0-7 days

Secondary outcomes

1

Duration of ICU stay

All days of life spent outside the intensive care unit within 60 days after inclusion in the study. A patient is given a value of 0 if they die before day 60 or are still receiving MV at day 60.

Time frame
0-60 days
2

Mechanical ventilation - Free Days

All days of life spent without mechanical ventilation. A patient is assigned a value of 0 if he or she dies before day 60 or continues to be on mechanical ventilation on day 60.

Time frame
0-60 days
3

Changes in oxygenation index

The change in value of oxygenation index (Pa02 / Fi02) from baseline (hour 0) at the initiation of hemoperfusion to 48 hours post-treatment initiation. Oxygenation index (OI) is commonly used to assess the severity of hypoxic respiratory failure (HRF).

Time frame
0-48 hours
4

SOFA score

Value of indicators on the Sequential Organ Failure Assessment (SOFA) Score. Each organ system received a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24. The change of SOFA score from baseline (hour 0) at the initiation of hemoperfusion to 48 hours post-treatment initiation.

Time frame
0-48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sergey Savko

Lead sponsor

City clinical hospital named after S. S. Yudin, Moscow City Health

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: