Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Time to Resolution of Cardiogenic Shock (Days) [Срок оценки: 1-7 days]

Вторичные конечные точки (7)

• Need for vasopressor support [Срок оценки: 0-72 hours]
• Pulmonary oxygen metabolic function [Срок оценки: 1-7 days]
• SOFA score [Срок оценки: 1-7 days]
• Duration of ventilation [Срок оценки: 1-7 days]
• ICU length of stay [Срок оценки: 1-7 days]
• Hospital length of stay [Срок оценки: 1-7 days]
• Incidence and severity of AKI [Срок оценки: 1-7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Tomsk NRMC Cardiology Research Institute — Tomsk

Идентификаторы

NCT: NCT06955936 · efferon-ct-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗