PMID- 37568295 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231103 IS - 2077-0383 (Print) IS - 2077-0383 (Electronic) IS - 2077-0383 (Linking) VI - 12 IP - 15 DP - 2023 Jul 25 TI - Impact of a VA-ECMO in Combination with an Extracorporeal Cytokine Hemadsorption System in Critically Ill Patients with Cardiogenic Shock-Design and Rationale of the ECMOsorb Trial. LID - 10.3390/jcm12154893 [doi] LID - 4893 AB - BACKGROUND: Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA-ECMO, clinical deterioration due to systemic inflammatory response syndrome (SIRS) resulting from the underlying shock and exposure of blood cells to the artificial surfaces of the ECMO circuit may occur. To address this issue, cytokine adsorbers offer a valuable solution by eliminating blood proteins, thereby controlling SIRS and potentially improving hemodynamics. Consequently, a prospective, randomized, blinded clinical trial will be carried out with ECMOsorb. METHODS AND STUDY DESIGN: ECMOsorb is a single-center, controlled, randomized, triple-blinded trial that will compare the hemodynamic effects of treatment with a VA-ECMO in combination with a cytokine adsorber (CytoSorb((R)), intervention) to treatment with VA-ECMO only (control) in patients with cardiogenic shock (with or without prior cardiopulmonary resuscitation (CPR)) requiring extracorporeal, hemodynamic support. Fifty-four patients will be randomized in a 1:1 fashion to the intervention or control group over a 36-month period. The primary endpoint of ECMOsorb is the improvement of the Inotropic Score (IS) 72 h after the intervention. Prognostic indicators, including mortality rates, hemodynamic parameters, laboratory findings, echocardiographic assessments, quality of life measurements, and clinical parameters, will serve as secondary outcome measures. The safety evaluation encompasses endpoints such as air embolisms, allergic reactions, peripheral ischemic complications, vascular complications, bleeding incidents, and stroke occurrences. CONCLUSIONS: The ECMOsorb trial seeks to assess the efficacy of a cytokine adsorber (CytoSorb((R)); CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA-ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery. FAU - Haertel, Franz AU - Haertel F AUID- ORCID: 0000-0002-4883-5176 AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Lehmann, Thomas AU - Lehmann T AD - Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany. FAU - Heller, Tabitha AU - Heller T AD - Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany. FAU - Fritzenwanger, Michael AU - Fritzenwanger M AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Pfeifer, Ruediger AU - Pfeifer R AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Kretzschmar, Daniel AU - Kretzschmar D AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Otto, Sylvia AU - Otto S AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Bogoviku, Jurgen AU - Bogoviku J AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Westphal, Julian AU - Westphal J AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Bruening, Christiane AU - Bruening C AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Gecks, Thomas AU - Gecks T AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Kaluza, Mirko AU - Kaluza M AD - Department of Cardiothoracic Surgery, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Moebius-Winkler, Sven AU - Moebius-Winkler S AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. FAU - Schulze, P Christian AU - Schulze PC AUID- ORCID: 0000-0001-9442-7141 AD - Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany. LA - eng GR - Vertrag Nr. I 5630/CytoSorbents (Germany)/ PT - Journal Article DEP - 20230725 PL - Switzerland TA - J Clin Med JT - Journal of clinical medicine JID - 101606588 PMC - PMC10420280 OTO - NOTNLM OT - CytoSorb(R) OT - ECMO OT - ICU OT - acute heart failure OT - cytokine removal OT - extracorporeal mechanical circulatory support OT - shock COIS- The authors declare no conflict of interest. EDAT- 2023/08/12 10:49 MHDA- 2023/08/12 10:50 PMCR- 2023/07/25 CRDT- 2023/08/12 01:01 PHST- 2023/05/26 00:00 [received] PHST- 2023/07/12 00:00 [revised] PHST- 2023/07/17 00:00 [accepted] PHST- 2023/08/12 10:50 [medline] PHST- 2023/08/12 10:49 [pubmed] PHST- 2023/08/12 01:01 [entrez] PHST- 2023/07/25 00:00 [pmc-release] AID - jcm12154893 [pii] AID - jcm-12-04893 [pii] AID - 10.3390/jcm12154893 [doi] PST - epublish SO - J Clin Med. 2023 Jul 25;12(15):4893. doi: 10.3390/jcm12154893.