An interventional study of Efferon CT in Myocardial Infarction and Cardiogenic Shock, sponsored by Efferon JSC. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Efferon JSC · Not applicable, Interventional, and Treatment
Cardiogenic shock is the most severe manifestation of acute heart failure and remains the leading cause of death in patients hospitalised with acute myocardial infarction.
Cardiogenic shock is a well-known and potent trigger of the immune response, ischemia/reperfusion organ damage, hemolysis and release of free hemoglobin. The activation of immune cells leads to the release of cytokines and inflammatory mediators such as IL-6, IL-8, activated complement and others. As a result of myocardial ischaemia and reperfusion injury, a multiorgan dysfunction syndrome may develop.
The Efferon CT hemoadsorption device effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa). This study evaluates whether this blood-filtering therapy can prevent organ failure in acute myocardial infarction patients with cardiogenic shock by eliminating inflammation-inducing mediators.
Cardiogenic shock (CS) is a state of acute critical tissue hypoperfusion caused by impaired myocardial contractility. It is one of the most serious complications of acute coronary syndrome (ACS), particularly acute myocardial infarction (AMI). Cardiogenic shock develops in approximately 30-40% of ACS patients, with a one-year mortality rate of 50-60%.
Despite advances in modern cardiology-including widespread use of timely revascularization, vasopressors, inotropic agents, and mechanical circulatory support-CS-related mortality remains unacceptably high. Efferent therapy, which modulates the homeostasis of biological fluids (e.g., blood) through physical and chemical methods (filtration, apheresis, sorption), represents a promising approach.
Recent studies on the hemoadsorbent CytoSorb in acute cardiac pathology demonstrated reductions in inflammatory markers (IL-6, lactate), improved hemodynamic stability, and lower 30-day ICU mortality (52% vs. 80% SOFA-predicted). These findings highlight the potential of cytokine adsorption to mitigate systemic inflammation in CS.
The Efferon CT hemoadsorption device, which effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa), may improve outcomes by alleviating CS symptoms and preventing multiple organ dysfunction.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Efferon JSC is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
Compared within Shock, Cardiogenic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Infarction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard therapy (according to the clinical guidelines "Cardiogenic Shock (2025)" issued by the "Russian Federation of Anaesthesiologists and Reanimatologists").
Standard therapy supplemented with a single session of hemoadsorption using Efferon CT.
Device: Efferon CT
Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoadsorption. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa. The therapy will be performed once no later than 4 hours after the diagnosis of cardiogenic shock. The duration of hemoadsorption is from 4 to 12 hours. The rate of hemoadsorption is from 80 to 150 ml/min. Anticoagulation is systemic (heparin or sodium citrate).
Time to Resolution of Cardiogenic Shock (Days)
Time from randomization to sustained hemodynamic stabilization, defined as: Mean arterial pressure (MAP) ≥65 mmHg and Heart rate ≤110 bpm and Cessation of vasopressors/inotropes (e.g., norepinephrine, dopamine) and mechanical circulatory support (MCS). Persistence of all criteria for ≥4 consecutive hours
Time frame: 1-7 days
Need for vasopressor support
Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score), measure every 12 hours. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.
Time frame: 0-72 hours
Pulmonary oxygen metabolic function
Measuring PaO2 / FiO2 index every 24 hours
Time frame: 1-7 days
SOFA score
The SOFA (Sequential Organ Failure Assessment) index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA index, the less pronounced organ failure and the better the patient's survival prognosis. Calculation every 24 hours.
Time frame: 1-7 days
Duration of ventilation
The time (hours) from the onset of hemoadsorption to the time of disconnection from the ventilator within 7 days or discharge from hospital or transfer from intensive care (if earlier than 7 days).
Time frame: 1-7 days
ICU length of stay
Time (days) from the start of hemoadsorption to transfer from the ICU within 7 days or hospital discharge (if earlier than day 7).
Time frame: 1-7 days
Hospital length of stay
Time (days) from the start of hemoadsorption to hospital discharge.
Time frame: 1-7 days
Incidence and severity of AKI
Frequency of AKI (AKI verified by KDIGO 2012 criteria) and duration (hours) of RRT in patients with AKI
Time frame: 1-7 days
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