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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Tomsk NRMC Cardiology Research Institute
RECRUITING
Tomsk
Contact Information
Primary
Alexandr Shelehov-Kravchenko, PhD, MD
alexandr.shelehov@gmail.com
+79636564765
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 60
Treatments
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.
Sponsors
Leads: Efferon JSC

This content was sourced from clinicaltrials.gov