Cytokine adsorption in patients with cardiac arrest receiving extracorporeal cardiopulmonary resuscitation (CAECR): a randomized controlled clinical trial protocol

Abstract

Introduction : Even after the introduction of extracorporeal cardiopulmonary resuscitation (ECPR), clinical prognosis following cardiac arrest (CA) remains poor. Post-cardiac arrest syndrome (PCAS) may contribute to cardiovascular instability and death after ECPR. Systemic inflammation constitutes is a significant component of PCAS, and the severity of PCAS is associated with the levels of inflammatory cytokines. Preliminary investigations supported further assessments of cytokine adsorption as adjunctive therapy for patients with Acute Respiratory Distress Syndrome (ARDS) and septic shock. This study aims to investigate whether cytokine adsorption can shorten the duration of Vein-Artery Extracorporeal Membrane Oxygenation (VA-ECMO) therapy in ECPR patients. Methods and analysis: The CAECR trial will be a single-center, randomized controlled, open-label trial. Patients will be randomized into two balanced parallel groups in a 1:1 ratio at the onset of ECMO initiation. Patients in the control group will undergo ECPR and receive standardized care, while those in the intervention group will undergo cytokine adsorption in addition to ECPR and receive standardized care. A 2-1-1 protocol will be adopted for cytokine adsorption: two units will be used for 12 h in the first 24 h, and then one unit per day for 24 h in the following 2 days. The primary outcome will be the duration of VA-ECMO therapy. The secondary outcomes will include related inflammatory markers, coagulation parameters, hemodynamic parameters, respiratory mechanics parameters, mechanical ventilation(MV) time, continuous renal replacement therapy(CRRT) time, and changes in vasoactive-inotropic score(VIS). To comprehensively evaluate the effect of cytokine adsorption on perioperative outcomes, we will also determine whether there are differences in the length of intensive care unit (ICU) stay, total hospitalization costs, and all-cause mortality.