Cytokine hemoadsorption in myocardial infarction-associated cardiogenic shock: protocol for a randomized clinical trial
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Aim. To evaluate the efficacy and safety of cytokine hemoadsorption using the Efferon®CT device in patients with myocardial Infarction-associated shock at SCAI (Society for Cardiovascular Angiography and Interventions) stages B-C. Material and methods. This is a protocol of an open-label, single-center, randomized controlled clinical trial. A total of 60 patients aged 18-80 years with myocardial Infarction-associated shock diagnosed within 4 hours prior to randomization will be enrolled. Participants will be randomized (1:1) to the intervention group (standard therapy + hemoadsorption, n=30) or the control group (standard therapy, n=30). Primary endpoint: time to clinical stabilization (hemodynamic normalization with discontinuation of vasopressor and mechanical support, sustained ≥4 hours). Secondary endpoints: hemodynamic parameters, oxygenation index, SOFA (Sequential Organ Failure Assessment) score, incidence of acute kidney injury (Kidney Disease: Improving Global Outcomes, KDIGO), duration and need for mechanical ventilation, intensive care unit and hospital length of stay, dynamics of inflammatory and organ function markers. Expected results. Hemoadsorption with Efferon®CT is expected to remove pro-inflammatory molecules of medium molecular weight, thereby improving macro- and microcirculation, reducing multiple organ dysfunction, and decreasing the need for vasopressor support. Conclusion. This study aims to provide the first evidence on the efficacy and safety of early cytokine hemoadsorption in myocardial Infarction-associated shock. The findings may support its pathophysiological rationale and form the basis for large-scale multicenter trials and potential updates of clinical practice guidelines.
Authors: M. A. Kercheva, S. V. Dil, A. A. Rumyantseva, O. O. Panteleev, I. V. Kologrivova, I. I. Yolgin, A. A. Dmitriukov, V. V. Ryabov
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4415568690