SepsisNCT07657767
Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels
A study testing Extracorporeal therapy and Extracorporeal elimination of cfDNA using "Nucleocore" in people with Sepsis, run by Sergey Savko at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Extracorporeal therapy and Extracorporeal elimination of cfDNA using "Nucleocore"
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jul 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nikolai Krotenko, Cand. of Sci. (Med.) contact
About this study
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.
Read the detailed description
Sepsis remains a critical challenge, associated with significant morbidity and mortality in modern healthcare. According to the latest definitions, sepsis is a clinical syndrome characterized by a dysregulated systemic response to infection that leads to organ failure. Recent breakthroughs in the pathophysiology of sepsis have identified key signaling molecules-including cytokines, toxins, and Damage-Associated Molecular Patterns (DAMPs)-that initiate and perpetuate this dysregulated immune response. As an adjunctive treatment, extracorporeal therapy has emerged as an effective strategy for the targeted elimination of these mediators. Current clinical and research modalities include non-selective hemoperfusion, which targets pro-inflammatory middle-molecular-weight proteins (10-60 kDa) such as Interleukin-1 (IL-1), Tumor Necrosis Factor-alpha (TNF-α), IL-2, IL-6, IL-8, IL-10, Interferon-gamma (IFN-γ), and complement proteins (e.g., CytoSorb and HA330 hemadsorption cartridges), and selective hemoperfusion, designed to eliminate Gram-negative bacterial lipopolysaccharides via affinity-binding fibers like Polymyxin B (e.g., Toraymyxin). A recent meta-analysis demonstrated that LPS-selective hemoperfusion significantly reduces mortality and endotoxin levels while stabilizing hemodynamic parameters. Furthermore, the EUPHRATES trial, the largest randomized controlled trial to date, demonstrated improvements in mean arterial pressure and 28-day survival exclusively within the subgroup of patients exhibiting endotoxin activity levels between 0.6 and 0.89. TPE serves as an alternative adjunctive therapy that entails the complete separation and removal of the patient's plasma from cellular components, thereby eliminating cytokines and toxins. A recent EXCHANGE-1 study demonstrated that TPE is associated with a reduction in acute-phase proteins and improved hemodynamics in patients with septic shock. Thus, the clinical potential of TPE in sepsis treatment remains a subject of active investigation.
A prominent frontier in sepsis research focuses on the extracorporeal removal of cfDNA and NETs, which are now recognized as critical drivers of systemic inflammation. Excessive circulating cfDNA acts as a (DAMP, further activating immune cells and the endothelium through the Toll-like receptor 9 (TLR9) signaling pathway. This process leads to cellular damage and microvascular thrombosis. Consequently, cfDNA serves as a primary driver of immunothrombosis-a state of inflammation-induced hypercoagulation. Furthermore, cfDNA is implicated in the pathogenesis of sepsis-associated acute kidney injury (AKI) and acute lung injury (ALI). These mechanisms provide a robust pathophysiological framework for therapies targeting the extracorporeal elimination of cfDNA in septic shock. The Nucleocor plasma adsorption column pioneers a novel approach by targeting these circulating DNA-containing structures to halt the amplification of systemic inflammation. To date, there are no universally accepted guidelines for the extracorporeal elimination of DNA-containing structures-such as cfDNA and NETs-from the systemic circulation in sepsis and septic shock. This study will evaluate the efficacy and safety of extracorporeal therapy using the Nucleocor plasma adsorption column in patients with septic shock characterized by prognostically unfavorable elevations in cfDNA levels. Representing a world-first technology, the Nucleocor adsorber is uniquely designed for the selective removal of DNA-containing molecular structures from the bloodstream. Ultimately, this project aims to establish a standardized protocol for this extracorporeal therapy and generate the evidence base required for its subsequent inclusion in national clinical guidelines
- Conditions
- Sepsis
- Being tested
- Extracorporeal therapy, Extracorporeal elimination of cfDNA using "Nucleocore"
- Keywords
- Sepsis, Extracorporeal therapy, cfDNA, Non-selective hemoperfusion
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal therapyDevice
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Extracorporeal therapy |
| Baseline therapy + Extracorporeal elimination of cfDNA | Other | Baseline therapy
+ Extracorporeal elimination of cfDNA using "Nucleocore" (NPO "Pokcard") Receives: Device: Extracorporeal therapy; Device: Extracorporeal elimination of cfDNA using "Nucleocore" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to Day 7
Secondary outcomes (13)
28-day mortality rate
The percentage of participants who died from any cause within 28 days following the allocation/procedure
Measured: Day 28
Duration of ICU stay
Total number of days from the date of ICU admission to the date of ICU discharge or death
Measured: Up to 28 days (or through hospital discharge)
Number of ventilator-free days
The number of days alive and free from mechanical ventilation (both invasive and non-invasive) within the first 28 days. If a participant dies within 28 days, the number of ventilator-free days is recorded as 0
Measured: Up to 28 days
Number of renal replacement therapy (RRT)-free days
The number of days alive and free from acute renal replacement therapy/dialysis within the first 28 days
Measured: Up to 28 days
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 24, 48, and 72 hours post-treatment initiation.
Measured: at baseline, 24, 48, and 72 hours post-hemosorption
Changes in oxygenation index
The change in value of oxygenation index (Pa02 / Fi02) from baseline (hour 0) at the initiation of hemoperfusion to 24, 48, and 72 hours post-treatment initiation
Measured: at baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in Vasoactive-Inotropic Score (VIS)
Evaluation of cardiovascular stability and the intensity of hemodynamic support using the Vasoactive-Inotropic Score (VIS)
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in inflammatory and tissue injury biomarkers
Evaluation of the time course of serum inflammatory and tissue damage markers, including Interleukin-6 (IL-6), C-reactive protein (CRP), procalcitonin (PCT), ferritin, and lactate dehydrogenase (LDH)
Measured: Baseline, 24, 48, and 72 hours post-hemosorption.
Change from baseline in hematological parameters
Evaluation of total white blood cell (WBC) count, differential leukocyte count via manual microscopic examination (including absolute counts and percentages of neutrophils, lymphocytes, and monocytes), and systemic inflammatory response indexes including the neutrophil-to-lymphocyte ratio (NLR)
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in bilirubin levels
Monitoring of hepatic excretory function and pigment metabolism via total bilirubin, direct bilirubin, and indirect bilirubin concentrations
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in blood lactate levels
Assessment of tissue perfusion and metabolic status through serial blood lactate measurements
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in coagulation parameters and thromboelastography (TEG) indices
Assessment of the plasma coagulation profile, including activated partial thromboplastin time (aPTT), international normalized ratio (INR), fibrinogen levels, plasma D-dimer concentrations, and antithrombin III (AT-III) activity, alongside the viscoelastic properties of whole blood measured via thromboelastography (TEG) parameters (reaction time [R], clot kinetics [K], alpha angle, and maximum amplitude [MA])
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in renal function parameters
Evaluation of renal excretory function via serial measurements of serum creatinine, blood urea
Measured: Baseline, 24, 48, and 72 hours post-hemosorption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start10 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergey Savko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sergey Savko, City clinical hospital named after S. S. Yudin, Moscow City Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657767
- Sponsor's protocol ID
- № 0910-4/25
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal cfDNA Removal in Septic Shock Patients With Elevated DNA Levels
- ClinicalTrials.gov ID
- NCT07657767
- Acronym / sponsor ID
- № 0910-4/25
- Conditions
- Sepsis
- Keywords
- Sepsis, Extracorporeal therapy, cfDNA, Non-selective hemoperfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sergey SavkoUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis remains a critical challenge, associated with significant morbidity and mortality in modern healthcare. According to the latest definitions, sepsis is a clinical syndrome characterized by a dysregulated systemic response to infection that leads to organ failure. Recent breakthroughs in the pathophysiology of sepsis have identified key signaling molecules-including cytokines, toxins, and Damage-Associated Molecular Patterns (DAMPs)-that initiate and perpetuate this dysregulated immune response. As an adjunctive treatment, extracorporeal therapy has emerged as an effective strategy for the targeted elimination of these mediators. Current clinical and research modalities include non-selective hemoperfusion, which targets pro-inflammatory middle-molecular-weight proteins (10-60 kDa) such as Interleukin-1 (IL-1), Tumor Necrosis Factor-alpha (TNF-α), IL-2, IL-6, IL-8, IL-10, Interferon-gamma (IFN-γ), and complement proteins (e.g., CytoSorb and HA330 hemadsorption cartridges), and selective hemoperfusion, designed to eliminate Gram-negative bacterial lipopolysaccharides via affinity-binding fibers like Polymyxin B (e.g., Toraymyxin). A recent meta-analysis demonstrated that LPS-selective hemoperfusion significantly reduces mortality and endotoxin levels while stabilizing hemodynamic parameters. Furthermore, the EUPHRATES trial, the largest randomized controlled trial to date, demonstrated improvements in mean arterial pressure and 28-day survival exclusively within the subgroup of patients exhibiting endotoxin activity levels between 0.6 and 0.89. TPE serves as an alternative adjunctive therapy that entails the complete separation and removal of the patient's plasma from cellular components, thereby eliminating cytokines and toxins. A recent EXCHANGE-1 study demonstrated that TPE is associated with a reduction in acute-phase proteins and improved hemodynamics in patients with septic shock. Thus, the clinical potential of TPE in sepsis treatment remains a subject of active investigation.
A prominent frontier in sepsis research focuses on the extracorporeal removal of cfDNA and NETs, which are now recognized as critical drivers of systemic inflammation. Excessive circulating cfDNA acts as a (DAMP, further activating immune cells and the endothelium through the Toll-like receptor 9 (TLR9) signaling pathway. This process leads to cellular damage and microvascular thrombosis. Consequently, cfDNA serves as a primary driver of immunothrombosis-a state of inflammation-induced hypercoagulation. Furthermore, cfDNA is implicated in the pathogenesis of sepsis-associated acute kidney injury (AKI) and acute lung injury (ALI). These mechanisms provide a robust pathophysiological framework for therapies targeting the extracorporeal elimination of cfDNA in septic shock. The Nucleocor plasma adsorption column pioneers a novel approach by targeting these circulating DNA-containing structures to halt the amplification of systemic inflammation. To date, there are no universally accepted guidelines for the extracorporeal elimination of DNA-containing structures-such as cfDNA and NETs-from the systemic circulation in sepsis and septic shock. This study will evaluate the efficacy and safety of extracorporeal therapy using the Nucleocor plasma adsorption column in patients with septic shock characterized by prognostically unfavorable elevations in cfDNA levels. Representing a world-first technology, the Nucleocor adsorber is uniquely designed for the selective removal of DNA-containing molecular structures from the bloodstream. Ultimately, this project aims to establish a standardized protocol for this extracorporeal therapy and generate the evidence base required for its subsequent inclusion in national clinical guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy | Other | Device: Extracorporeal therapyBaseline 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) |
| Baseline therapy + Extracorporeal elimination of cfDNA | Other | Device: Extracorporeal therapy, Device: Extracorporeal elimination of cfDNA using "Nucleocore"Baseline therapy + Extracorporeal elimination of cfDNA using "Nucleocore" (NPO "Pokcard") |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal therapyExtracorporeal therapy - only in case of AKI - in HD/CVVHD format using standard polysulfone filters with a permeability of no more than 30 kDa | Device | Baseline therapy, Baseline therapy + Extracorporeal elimination of cfDNA |
| 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. | Device | Baseline therapy + Extracorporeal elimination of cfDNA |
Primary outcome
cfDNA following the completion of extracorporeal therapy
Time frame: at baseline and 72 hours post-hemosorption
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
Rate of septic shock resolution by Day 7
Time frame: Up to 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.
13 secondary outcomes
28-day mortality rate
Time frame: Day 28
Duration of ICU stay
Time frame: Up to 28 days (or through hospital discharge)
Number of ventilator-free days
Time frame: Up to 28 days
Number of renal replacement therapy (RRT)-free days
Time frame: Up to 28 days
SOFA score
Time frame: at baseline, 24, 48, and 72 hours post-hemosorption
Changes in oxygenation index
Time frame: at baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in Vasoactive-Inotropic Score (VIS)
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in inflammatory and tissue injury biomarkers
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption.
Change from baseline in hematological parameters
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in bilirubin levels
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in blood lactate levels
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in coagulation parameters and thromboelastography (TEG) indices
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Change from baseline in renal function parameters
Time frame: Baseline, 24, 48, and 72 hours post-hemosorption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolai Krotenko, Cand. of Sci. (Med.) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal therapy and Extracorporeal elimination of cfDNA using "Nucleocore" in people with Sepsis, run by Sergey Savko at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Savko (89635156233, d.t.d.savko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cfDNA following the completion of extracorporeal therapy (time frame: at baseline and 72 hours post-hemosorption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.