Health Trials

Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

ConditionsMyocardial InfarctionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEfferon JSC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Broken-heart syndrome (takotsubo cardiomyopathy)

Postcardiotomy cardiogenic shock

Acute myocardial infarction within the last 4 weeks

Myocarditis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efferon CT

    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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Baseline therapyNo intervention 0 interventions
Group B: Basic therapy + Efferon CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Pulmonary oxygen metabolic function

Measuring PaO2 / FiO2 index every 24 hours

Time frame
1-7 days
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Efferon JSC

Lead sponsor

Source ClinicalTrials.gov
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