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Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial

BACKGROUND: Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing c...

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Autores principales: Poli, Elettra C, Alberio, Lorenzo, Bauer-Doerries, Anna, Marcucci, Carlo, Roumy, Aurélien, Kirsch, Matthias, De Stefano, Eleonora, Liaudet, Lucas, Schneider, Antoine G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6448322/
https://www.ncbi.nlm.nih.gov/pubmed/30944029
http://dx.doi.org/10.1186/s13054-019-2399-4
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author Poli, Elettra C
Alberio, Lorenzo
Bauer-Doerries, Anna
Marcucci, Carlo
Roumy, Aurélien
Kirsch, Matthias
De Stefano, Eleonora
Liaudet, Lucas
Schneider, Antoine G
author_facet Poli, Elettra C
Alberio, Lorenzo
Bauer-Doerries, Anna
Marcucci, Carlo
Roumy, Aurélien
Kirsch, Matthias
De Stefano, Eleonora
Liaudet, Lucas
Schneider, Antoine G
author_sort Poli, Elettra C
collection PubMed
description BACKGROUND: Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb® (Cytosorbents, NJ, USA) is a recent device designed to remove cytokine from the blood using haemoadsorption (HA). This trial aims to evaluate the potential of CytoSorb® to decrease peri-operative cytokine levels in cardiac surgery. METHODS: We have conducted a single-centre pilot randomized controlled trial in 30 patients undergoing elective cardiac surgery and deemed at risk of complications. Patients were randomly allocated to either standard of care (n = 15) or CytoSorb® HA (n = 15) during cardiopulmonary bypass (CPB). Our primary outcome was the difference between the two groups in cytokines levels (IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-10, TNF-α, IFN-γ, MCP-1) measured at anaesthesia induction, at the end of CPB, as well as 6 and 24 h post-CPB initiation. In a consecutive subgroup of patients (10 in HA group, 11 in control group), we performed cross-adsorber as well as serial measurements of coagulation factors’ activity (antithrombin, von Willebrand factor, factor II, V, VIII, IX, XI, and XII). RESULTS: Both groups were similar in terms of baseline and peri-operative characteristics. CytoSorb® HA during CPB was not associated with an increased incidence of adverse event. The procedure did not result in significant coagulation factors’ adsorption but only some signs of coagulation activation. However, the intervention was associated neither with a decrease in pro- or anti-inflammatory cytokine levels nor with any improvement in relevant clinical outcomes. CONCLUSIONS: CytoSorb® HA during CPB was not associated with a decrease in pro- or anti-inflammatory cytokines nor with an improvement in relevant clinical outcomes. The procedure was feasible and safe. Further studies should evaluate the efficacy of CytoSorb® HA in other clinical contexts. TRIAL REGISTRATION: ClinicalTrials.gov NCT02775123. Registered 17 May 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13054-019-2399-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-64483222019-04-15 Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial Poli, Elettra C Alberio, Lorenzo Bauer-Doerries, Anna Marcucci, Carlo Roumy, Aurélien Kirsch, Matthias De Stefano, Eleonora Liaudet, Lucas Schneider, Antoine G Crit Care Research BACKGROUND: Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb® (Cytosorbents, NJ, USA) is a recent device designed to remove cytokine from the blood using haemoadsorption (HA). This trial aims to evaluate the potential of CytoSorb® to decrease peri-operative cytokine levels in cardiac surgery. METHODS: We have conducted a single-centre pilot randomized controlled trial in 30 patients undergoing elective cardiac surgery and deemed at risk of complications. Patients were randomly allocated to either standard of care (n = 15) or CytoSorb® HA (n = 15) during cardiopulmonary bypass (CPB). Our primary outcome was the difference between the two groups in cytokines levels (IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-10, TNF-α, IFN-γ, MCP-1) measured at anaesthesia induction, at the end of CPB, as well as 6 and 24 h post-CPB initiation. In a consecutive subgroup of patients (10 in HA group, 11 in control group), we performed cross-adsorber as well as serial measurements of coagulation factors’ activity (antithrombin, von Willebrand factor, factor II, V, VIII, IX, XI, and XII). RESULTS: Both groups were similar in terms of baseline and peri-operative characteristics. CytoSorb® HA during CPB was not associated with an increased incidence of adverse event. The procedure did not result in significant coagulation factors’ adsorption but only some signs of coagulation activation. However, the intervention was associated neither with a decrease in pro- or anti-inflammatory cytokine levels nor with any improvement in relevant clinical outcomes. CONCLUSIONS: CytoSorb® HA during CPB was not associated with a decrease in pro- or anti-inflammatory cytokines nor with an improvement in relevant clinical outcomes. The procedure was feasible and safe. Further studies should evaluate the efficacy of CytoSorb® HA in other clinical contexts. TRIAL REGISTRATION: ClinicalTrials.gov NCT02775123. Registered 17 May 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13054-019-2399-4) contains supplementary material, which is available to authorized users. BioMed Central 2019-04-03 /pmc/articles/PMC6448322/ /pubmed/30944029 http://dx.doi.org/10.1186/s13054-019-2399-4 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Poli, Elettra C
Alberio, Lorenzo
Bauer-Doerries, Anna
Marcucci, Carlo
Roumy, Aurélien
Kirsch, Matthias
De Stefano, Eleonora
Liaudet, Lucas
Schneider, Antoine G
Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title_full Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title_fullStr Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title_full_unstemmed Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title_short Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial
title_sort cytokine clearance with cytosorb® during cardiac surgery: a pilot randomized controlled trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6448322/
https://www.ncbi.nlm.nih.gov/pubmed/30944029
http://dx.doi.org/10.1186/s13054-019-2399-4
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