Cargando…
CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry
Introduction: CytoSorb extracorporeal blood purification therapy received FDA Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients. The multicenter CTC Registry was established to systematically collect patient-level data, outcomes, and utilization patt...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720923/ https://www.ncbi.nlm.nih.gov/pubmed/34988092 http://dx.doi.org/10.3389/fmed.2021.773461 |
_version_ | 1784625228861669376 |
---|---|
author | Song, Tae Hayanga, Jeremiah Durham, Lucian Garrison, Lawrence McCarthy, Paul Barksdale, Andy Smith, Deane Bartlett, Robert Jaros, Mark Nelson, Peter Molnar, Zsolt Deliargyris, Efthymios Moazami, Nader |
author_facet | Song, Tae Hayanga, Jeremiah Durham, Lucian Garrison, Lawrence McCarthy, Paul Barksdale, Andy Smith, Deane Bartlett, Robert Jaros, Mark Nelson, Peter Molnar, Zsolt Deliargyris, Efthymios Moazami, Nader |
author_sort | Song, Tae |
collection | PubMed |
description | Introduction: CytoSorb extracorporeal blood purification therapy received FDA Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients. The multicenter CTC Registry was established to systematically collect patient-level data, outcomes, and utilization patterns of CytoSorb under the EUA. Methods: Patient-level data was entered retrospectively at participating centers. The primary outcome of the registry was ICU mortality. Patient disposition of death, continuing ICU care, or ICU discharge was analyzed up to Day 90 after start of CytoSorb therapy. Demographics, comorbidities, COVID-19 medications, inflammatory biomarkers, and details on CytoSorb use were compared between survivors and non-survivors in the veno-venous extracorporeal membrane oxygenation (ECMO) cohort. Results: Between April 2020 and April 2021, 52 patients received veno-venous ECMO plus CytoSorb therapy at 5 U.S. centers. ICU mortality was 17.3% (9/52) on day 30, 26.9% (14/52) on day 90, and 30.8% (16/52) at final follow-up of 153 days. Survivors had a trend toward lower baseline D-Dimer levels (2.3 ± 2.5 vs. 19.8 ± 32.2 μg/mL, p = 0.056) compared to non-survivors. A logistic regression analysis suggested a borderline association between baseline D-Dimer levels and mortality with a 32% increase in the risk of death per 1 μg/mL increase (p = 0.055). CytoSorb was well-tolerated without any device-related adverse events reported. Conclusions: CytoSorb therapy for critically ill COVID-19 patients on ECMO was associated with high survival rates suggesting potential therapeutic benefit. Elevated baseline D-Dimer levels may suggest increased risk of mortality. Prospective controlled studies are warranted to substantiate these results. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT0439192, identifier: NCT04391920. |
format | Online Article Text |
id | pubmed-8720923 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-87209232022-01-04 CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry Song, Tae Hayanga, Jeremiah Durham, Lucian Garrison, Lawrence McCarthy, Paul Barksdale, Andy Smith, Deane Bartlett, Robert Jaros, Mark Nelson, Peter Molnar, Zsolt Deliargyris, Efthymios Moazami, Nader Front Med (Lausanne) Medicine Introduction: CytoSorb extracorporeal blood purification therapy received FDA Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients. The multicenter CTC Registry was established to systematically collect patient-level data, outcomes, and utilization patterns of CytoSorb under the EUA. Methods: Patient-level data was entered retrospectively at participating centers. The primary outcome of the registry was ICU mortality. Patient disposition of death, continuing ICU care, or ICU discharge was analyzed up to Day 90 after start of CytoSorb therapy. Demographics, comorbidities, COVID-19 medications, inflammatory biomarkers, and details on CytoSorb use were compared between survivors and non-survivors in the veno-venous extracorporeal membrane oxygenation (ECMO) cohort. Results: Between April 2020 and April 2021, 52 patients received veno-venous ECMO plus CytoSorb therapy at 5 U.S. centers. ICU mortality was 17.3% (9/52) on day 30, 26.9% (14/52) on day 90, and 30.8% (16/52) at final follow-up of 153 days. Survivors had a trend toward lower baseline D-Dimer levels (2.3 ± 2.5 vs. 19.8 ± 32.2 μg/mL, p = 0.056) compared to non-survivors. A logistic regression analysis suggested a borderline association between baseline D-Dimer levels and mortality with a 32% increase in the risk of death per 1 μg/mL increase (p = 0.055). CytoSorb was well-tolerated without any device-related adverse events reported. Conclusions: CytoSorb therapy for critically ill COVID-19 patients on ECMO was associated with high survival rates suggesting potential therapeutic benefit. Elevated baseline D-Dimer levels may suggest increased risk of mortality. Prospective controlled studies are warranted to substantiate these results. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT0439192, identifier: NCT04391920. Frontiers Media S.A. 2021-12-20 /pmc/articles/PMC8720923/ /pubmed/34988092 http://dx.doi.org/10.3389/fmed.2021.773461 Text en Copyright © 2021 Song, Hayanga, Durham, Garrison, McCarthy, Barksdale, Smith, Bartlett, Jaros, Nelson, Molnar, Deliargyris and Moazami. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Song, Tae Hayanga, Jeremiah Durham, Lucian Garrison, Lawrence McCarthy, Paul Barksdale, Andy Smith, Deane Bartlett, Robert Jaros, Mark Nelson, Peter Molnar, Zsolt Deliargyris, Efthymios Moazami, Nader CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title | CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title_full | CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title_fullStr | CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title_full_unstemmed | CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title_short | CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry |
title_sort | cytosorb therapy in covid-19 (ctc) patients requiring extracorporeal membrane oxygenation: a multicenter, retrospective registry |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720923/ https://www.ncbi.nlm.nih.gov/pubmed/34988092 http://dx.doi.org/10.3389/fmed.2021.773461 |
work_keys_str_mv | AT songtae cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT hayangajeremiah cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT durhamlucian cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT garrisonlawrence cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT mccarthypaul cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT barksdaleandy cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT smithdeane cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT bartlettrobert cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT jarosmark cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT nelsonpeter cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT molnarzsolt cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT deliargyrisefthymios cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry AT moazaminader cytosorbtherapyincovid19ctcpatientsrequiringextracorporealmembraneoxygenationamulticenterretrospectiveregistry |