Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

An Open Randomized Study on the Efficacy and Safety of Hemoadsorption With Efferon CT in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Cardiogenic Shock
• Intervention / Treatment: Device: Efferon CT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandr Shelehov-Kravchenko, PhD, MD; Phone Number: +79636564765; Email: alexandr.shelehov@gmail.com

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Recruiting
    • Tomsk NRMC Cardiology Research Institute
    • Contact: Vyacheslav Ryabov, PhD, MD; Phone Number: +79069481480; Email: rvvt@cardio-tomsk.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not more than 4 hours after diagnosis Cardiogenic shock complicating acute myocardial infarction
• Stages B - C of cardiogenic shock according to SCAI
• Patient condition allows treatment with Efferon® CT device for at least 4 hours
• SOFA score 12 or less

Exclusion Criteria:

• Broken-heart syndrome (takotsubo cardiomyopathy)
• Postcardiotomy cardiogenic shock
• Acute myocardial infarction within the last 4 weeks
• Myocarditis
• Cardiac trauma
• Charlson comorbidity index greater than 9 points
• Chronic kidney disease, stage 5 D (requiring continuous hemodialysis)
• Acute pulmonary embolism
• Acute cerebral circulatory collapse
• Transfusion reaction
• Patients on immunosuppressive therapy for cancer and autoimmune diseases
• Pregnancy
• Any other clinical condition of the patient that in the opinion of the investigator precludes inclusion in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline therapy; Standard therapy (according to the clinical guidelines "Cardiogenic Shock (2025)" issued by the "Russian Federation of Anaesthesiologists and Reanimatologists").
Experimental: Basic therapy + Efferon CT; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-72 hours
Pulmonary oxygen metabolic function	Measuring PaO2 / FiO2 index every 24 hours	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.	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).	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).	1-7 days
Hospital length of stay	Time (days) from the start of hemoadsorption to hospital discharge.	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	1-7 days

Collaborators and Investigators

• Sponsor: Efferon JSC
• Investigators: Principal Investigator: Vyacheslav Ryabov, PhD, MD, Tomsk NRMC Cardiology Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Hemoperfusion; Hemoadsorption; Extracorporeal therapy; Cytokine adsorption
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Shock, Cardiogenic; Shock; Myocardial Infarction; Infarction
• Other Study ID Numbers: efferon-ct-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No