Mahmoud Diab1,2, Thomas Lehmann2,3, Wolfgang Bothe4, Payam Akhyari5, Stephanie Platzer2,3, Daniel Wendt6, Antje-Christin Deppe7, Justus Strauch8, Stefan Hagel9, Albrecht Günther10, Gloria Faerber1, Christoph Sponholz11, Marcus Franz12, André Scherag2,3,13, Ilia Velichkov1, Miriam Silaschi14, Jens Fassl15, Britt Hofmann16, Sven Lehmann17, Rene Schramm18, Georg Fritz19, Gabor Szabo16, Thorsten Wahlers7, Klaus Matschke20, Artur Lichtenberg5, Mathias W Pletz9, Jan F Gummert18, Friedhelm Beyersdorf4, Christian Hagl21,22, Michael A Borger17, Michael Bauer2,11, Frank M Brunkhorst2,3, Torsten Doenst1. 1. Department of Cardiothoracic Surgery (M.D., G. Faerber, I.V., T.D.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 2. Center for Sepsis Control and Care (M.D., T.L., S.P., A.S., M.B., F.M.B.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 3. Center for Clinical Studies (T.L., S.P., A.S., F.M.B.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 4. Department of Cardiovascular Surgery, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany (W.B., F.B.). 5. Department of Cardiothoracic Surgery, Heinrich-Heine-University Duesseldorf, Germany (P.A., A.L.). 6. Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, Germany (D.W.). 7. Department of Cardiothoracic Surgery, Heart Center of the University of Cologne, Germany (A.-C.D., T.W.). 8. Department of Cardiac and Thoracic Surgery, Bergmannsheil University Hospitals, Bochum, Germany (J.S.). 9. Institute for Infectious Diseases and Infection Control (S.H., M.W.P.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 10. Department of Neurology (A.G.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 11. Department of Anesthesiology and Critical Care Medicine (C.S., M.B.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 12. Department of Internal Medicine I (M.F.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 13. Institute of Medical Statistics, Computer and Data Sciences (A.S.), Jena University Hospital-Friedrich Schiller University of Jena, Germany. 14. Clinic and Polyclinic for Cardiac Surgery, University Hospital Bonn, Germany (M.S.). 15. Institute for Cardiac Anesthesiology, Dresden Heart Center, University Hospital at the Technical University Dresden, Germany (J.F.). 16. Department of Cardiac Surgery, Mid-German Heart Center, University Hospital Halle (Saale), Halle, Germany (B.H., G.S.). 17. Department of Cardiac Surgery, Heart Center Leipzig, Germany (S.L., M.A.B.). 18. Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany (R.S., J.F.G.). 19. Department of Anesthesiology, Intensive Care and Pain Therapy, Heart Center Brandenburg, Immanuel Clinic Bernau, Germany (G. Fritz). 20. Department of Cardiac Surgery, Heart Center Dresden, Germany (K.M.). 21. Department of Cardiac Surgery, Ludwig Maximilian University Munich, Germany (C.H.). 22. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany (C.H.).
Abstract
BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1β and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.
BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [ΔSOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for ΔSOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, ΔSOFA, did not differ between the hemoadsorption and the control group (1.79±3.75 and 1.93±3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1β and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03266302.
Entities:
Keywords:
cardiopulmonary bypass; cytokines; endocarditis; thoracic surgery
Authors: Jurij Matija Kalisnik; Spela Leiler; Hazem Mamdooh; Janez Zibert; Thomas Bertsch; Ferdinand Aurel Vogt; Erik Bagaev; Matthias Fittkau; Theodor Fischlein Journal: J Clin Med Date: 2022-07-07 Impact factor: 4.964