{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T23:28:47Z","timestamp":1792452527297,"version":"4.5.0"},"reference-count":33,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2023,7,25]],"date-time":"2023-07-25T00:00:00Z","timestamp":1690243200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"CytoSorbents Europe GmbH"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Cardiogenic shock and arrest present as critical, life-threatening emergencies characterized by severely compromised tissue perfusion and inadequate oxygen supply. Veno\u2013arterial extracorporeal membrane oxygenation (VA\u2013ECMO) serves as a mechanical support system for patients suffering shock refractory to conventional resuscitation. Despite the utilization of VA\u2013ECMO, 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\u2013ECMO in combination with a cytokine adsorber (CytoSorb\u00ae, intervention) to treatment with VA\u2013ECMO 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\u00ae; CytoSorbents Europe GmbH, Berlin, Germany) in reducing SIRS and improving hemodynamics in patients with cardiogenic shock who are receiving VA\u2013ECMO. We hypothesize that a reduction in cytokine levels can lead to faster weaning from inotropic and mechanical circulatory support, and ultimately to improved recovery.<\/jats:p>","DOI":"10.3390\/jcm12154893","type":"journal-article","created":{"date-parts":[[2023,7,26]],"date-time":"2023-07-26T01:09:01Z","timestamp":1690333741000},"page":"4893","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Impact of a VA\u2013ECMO in Combination with an Extracorporeal Cytokine Hemadsorption System in Critically Ill Patients with Cardiogenic Shock\u2013Design and Rationale of the ECMOsorb Trial"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4883-5176","authenticated-orcid":false,"given":"Franz","family":"Haertel","sequence":"first","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lehmann","sequence":"additional","affiliation":[{"name":"Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tabitha","family":"Heller","sequence":"additional","affiliation":[{"name":"Center of Clinical Studies, University Hospital Jena, Salvador-Allende-Platz 27, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Fritzenwanger","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruediger","family":"Pfeifer","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Kretzschmar","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia","family":"Otto","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jurgen","family":"Bogoviku","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian","family":"Westphal","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christiane","family":"Bruening","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Gecks","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirko","family":"Kaluza","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven","family":"Moebius-Winkler","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9442-7141","authenticated-orcid":false,"given":"P. Christian","family":"Schulze","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care, University Hospital Jena, Am Klinikum 1, 07747 Jena, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,7,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.resuscitation.2021.02.007","article-title":"European Resuscitation Council Guidelines 2021: Epidemiology of cardiac arrest in Europe","volume":"161","author":"Herlitz","year":"2021","journal-title":"Resuscitation"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1219","DOI":"10.1016\/j.resuscitation.2010.08.021","article-title":"European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary","volume":"81","author":"Nolan","year":"2010","journal-title":"Resuscitation"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1016\/j.resuscitation.2018.05.004","article-title":"Early ECPR for out-of-hospital cardiac arrest: Best practice in 2018","volume":"130","author":"Hutin","year":"2018","journal-title":"Resuscitation"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1007\/s12181-018-0268-z","article-title":"Empfehlungen zur extrakorporalen kardiopulmonalen Reanimation (eCPR)","volume":"12","author":"Michels","year":"2018","journal-title":"Der Kardiol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1016\/j.resuscitation.2016.01.019","article-title":"Comparing extracorporeal cardiopulmonary resuscitation with conventional cardiopulmonary resuscitation: A meta-analysis","volume":"103","author":"Kim","year":"2016","journal-title":"Resuscitation"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"100","DOI":"10.1016\/j.resuscitation.2015.07.016","article-title":"European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support","volume":"95","author":"Soar","year":"2015","journal-title":"Resuscitation"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"2469","DOI":"10.1016\/j.jcin.2017.08.055","article-title":"Early Risk Stratification in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction Treated With Extracorporeal Life Support and Primary Percutaneous Coronary Intervention","volume":"10","author":"Vdovin","year":"2017","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1016\/S0140-6736(08)60958-7","article-title":"Cardiopulmonary resuscitation with assisted extracorporeal life-support versus conventional cardiopulmonary resuscitation in adults with in-hospital cardiac arrest: An observational study and propensity analysis","volume":"372","author":"Chen","year":"2008","journal-title":"Lancet"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1186\/s13054-017-1744-8","article-title":"Influence of low-flow time on survival after extracorporeal cardiopulmonary resuscitation (eCPR)","volume":"21","author":"Wengenmayer","year":"2017","journal-title":"Crit. Care"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1223","DOI":"10.1097\/CCM.0000000000000937","article-title":"Systemic Inflammatory Response and Potential Prognostic Implications After Out-of-Hospital Cardiac Arrest: A Substudy of the Target Temperature Management Trial","volume":"43","author":"Kjaergaard","year":"2015","journal-title":"Crit. Care Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1655","DOI":"10.1001\/archinte.167.15.1655","article-title":"Faculty Opinions recommendation of Understanding the inflammatory cytokine response in pneumonia and sepsis: Results of the Genetic and Inflammatory Markers of Sepsis (GenIMS) Study","volume":"167","author":"Kellum","year":"2007","journal-title":"Arch. Intern. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1159\/000500015","article-title":"Rationale of Hemoadsorption during Extracorporeal Membrane Oxygenation Support","volume":"48","author":"Napp","year":"2019","journal-title":"Blood Purif."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1186\/1749-8090-8-186","article-title":"The effect of venovenous extra-corporeal membrane oxygenation (ECMO) therapy on immune inflammatory response of cerebral tissues in porcine model","volume":"8","author":"Chen","year":"2013","journal-title":"J. Cardiothorac. Surg."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1097\/CCM.0b013e3181feeb15","article-title":"Fluid resuscitation in septic shock: A positive fluid balance and elevated central venous pressure are associated with increased mortality","volume":"39","author":"Boyd","year":"2011","journal-title":"Crit. Care Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"R181","DOI":"10.1186\/cc8167","article-title":"Association of arterial blood pressure and vasopressor load with septic shock mortality: A post hoc analysis of a multicenter trial","volume":"13","author":"Ruokonen","year":"2009","journal-title":"Crit. Care"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"208","DOI":"10.1186\/s13054-016-1387-1","article-title":"Current real-life use of vasopressors and inotropes in cardiogenic shock\u2014Adrenaline use is associated with excess organ injury and mortality","volume":"20","author":"Tarvasmaki","year":"2016","journal-title":"Crit. Care"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1111\/j.1540-8191.1999.tb00996.x","article-title":"Pharmacological Criteria for Ventricular Assist Device Insertion Following Postcardiotomy Shock: Experience with the Abiomed BVS System","volume":"14","author":"Samuels","year":"1999","journal-title":"J. Card. Surg."},{"key":"ref_18","first-page":"410","article-title":"Immunomodulation in sepsis: The role of hemofiltration","volume":"65","author":"Kellum","year":"1999","journal-title":"Minerva Anestesiol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1097\/00003246-200301000-00060","article-title":"Hemoadsorption therapy for sepsis syndromes","volume":"31","author":"Kellum","year":"2003","journal-title":"Crit. Care Med."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"801","DOI":"10.1097\/01.CCM.0000114997.39857.69","article-title":"Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-\u03baB DNA binding, and improves short-term survival in lethal endotoxemia","volume":"32","author":"Kellum","year":"2004","journal-title":"Crit. Care Med."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1056\/NEJMoa1705835","article-title":"Adjunctive Glucocorticoid Therapy in Patients with Septic Shock","volume":"378","author":"Venkatesh","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1186\/s13054-014-0699-2","article-title":"The efficacy and safety of plasma exchange in patients with sepsis and septic shock: A systematic review and meta-analysis","volume":"18","author":"Rimmer","year":"2014","journal-title":"Crit. Care"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1154","DOI":"10.1001\/jama.2013.2194","article-title":"Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: The ACCESS randomized trial","volume":"309","author":"Opal","year":"2013","journal-title":"JAMA"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1097\/01.CCM.0000105581.01815.C6","article-title":"Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: Effect on survival in patients with septic shock","volume":"32","author":"Lorente","year":"2004","journal-title":"Crit. Care Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1097\/CCM.0000000000000554","article-title":"Multicenter, Randomized, Placebo-Controlled Phase III Study of Pyridoxalated Hemoglobin Polyoxyethylene in Distributive Shock (PHOENIX)","volume":"43","author":"Vincent","year":"2015","journal-title":"Crit. Care Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1056\/NEJM199102143240701","article-title":"Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin. A randomized, double-blind, placebo-controlled trial. The HA-1A Sepsis Study Group","volume":"324","author":"Ziegler","year":"1991","journal-title":"N. Engl. J. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"3599","DOI":"10.1093\/eurheartj\/ehab368","article-title":"2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure","volume":"42","author":"McDonagh","year":"2021","journal-title":"Eur. Heart J."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"779","DOI":"10.1056\/NEJMoa0907118","article-title":"Comparison of dopamine and norepinephrine in the treatment of shock","volume":"362","author":"Biston","year":"2010","journal-title":"N. Engl. J. Med."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1186\/s13054-021-03468-x","article-title":"Blood purification with a cytokine adsorber for the elimination of myoglobin in critically ill patients with severe rhabdomyolysis","volume":"25","author":"Scharf","year":"2021","journal-title":"Crit. Care"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1007\/s00059-016-4523-4","article-title":"ECMO in cardiac arrest and cardiogenic shock","volume":"42","author":"Napp","year":"2017","journal-title":"Herz"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1007\/s00392-015-0941-1","article-title":"Cannulation strategies for percutaneous extracorporeal membrane oxygenation in adults","volume":"105","author":"Napp","year":"2016","journal-title":"Clin. Res. Cardiol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"e231","DOI":"10.1016\/j.jcin.2017.07.047","article-title":"First-in-Man Fully Percutaneous Complete Bypass of Heart and Lung","volume":"10","author":"Napp","year":"2017","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1186\/s13054-023-04492-9","article-title":"Efficacy of CytoSorb(R): A systematic review and meta-analysis","volume":"27","author":"Becker","year":"2023","journal-title":"Crit. Care"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/15\/4893\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T20:18:57Z","timestamp":1760127537000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/15\/4893"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7,25]]},"references-count":33,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2023,8]]}},"alternative-id":["jcm12154893"],"URL":"https:\/\/doi.org\/10.3390\/jcm12154893","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7,25]]}}}