Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

NCT ID: NCT06955936

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-29
• Study Completion Date: 2027-07-31

Brief Summary

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.

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.

Conditions

Myocardial Infarction; Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline therapy

Standard therapy (according to the clinical guidelines "Cardiogenic Shock (2025)" issued by the "Russian Federation of Anaesthesiologists and Reanimatologists").

Group Type: NO_INTERVENTION

No interventions assigned to this group

Basic therapy + Efferon CT

Standard therapy supplemented with a single session of hemoadsorption using Efferon CT.

Group Type: EXPERIMENTAL

Efferon CT

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vyacheslav Ryabov, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC Cardiology Research Institute

Locations

Tomsk NRMC Cardiology Research Institute

Tomsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

Role: CONTACT

alexandr.shelehov@gmail.com

+79636564765

Facility Contacts

Vyacheslav Ryabov, PhD, MD

Role: primary

rvvt@cardio-tomsk.ru

+79069481480

Other Identifiers

efferon-ct-2025-01

Identifier Type: -

Identifier Source: org_study_id