Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation (CYCOV): a single centre, open-label, randomised, controlled trial
Autor: | Franziska Frech, Achim Lother, Christoph Bode, Tim Niklaus, Viviane Zotzmann, Georg Trummer, Kirsten Krüger, Erika Graf, Christoph Benk, Sissi Müller, Asieb Sekandarzad, Timm Zahn, Tobias Wengenmayer, Sven Maier, Paul Biever, Enya Weber, Dawid L. Staudacher, Daniel Duerschmied, Marina Rieder, Alexander Supady, Peter Stachon, Annabelle Flügler, Moritz Kuhl |
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Rok vydání: | 2021 |
Předmět: |
Pulmonary and Respiratory Medicine
Intention-to-treat analysis business.industry medicine.medical_treatment medicine.disease law.invention Clinical trial 03 medical and health sciences Pneumonia 0302 clinical medicine Cytokine Adsorption 030228 respiratory system Randomized controlled trial law Anesthesia medicine Clinical endpoint Extracorporeal membrane oxygenation 030212 general & internal medicine business |
Zdroj: | The Lancet Respiratory Medicine. 9:755-762 |
ISSN: | 2213-2600 0432-4528 |
Popis: | BACKGROUND: We sought to clarify the benefit of cytokine adsorption in patients with COVID-19 supported with venovenous extracorporeal membrane oxygenation (ECMO). METHODS: We did a single-centre, open-label, randomised, controlled trial to investigate cytokine adsorption in adult patients with severe COVID-19 pneumonia requiring ECMO. Patients with COVID-19 selected for ECMO at the Freiburg University Medical Center (Freiburg, Germany) were randomly assigned (1:1) to receive cytokine adsorption using the CytoSorb device or not. Randomisation was computer-generated, allocation was concealed by opaque, sequentially numbered sealed envelopes. The CytoSorb device was incorporated into the ECMO circuit before connection to the patient circuit, replaced every 24 h, and removed after 72 h. The primary endpoint was serum interleukin-6 (IL-6) concentration 72 h after initiation of ECMO analysed by intention to treat. Secondary endpoints included 30-day survival. The trial is registered with ClinicalTrials.gov (NCT04324528) and the German Clinical Trials Register (DRKS00021300) and is closed. FINDINGS: From March 29, 2020, to Dec 29, 2020, of 34 patients assessed for eligibility, 17 (50%) were treated with cytokine adsorption and 17 (50%) without. Median IL-6 decreased from 357·0 pg/mL to 98·6 pg/mL in patients randomly assigned to cytokine adsorption and from 289·0 pg/mL to 112·0 pg/mL in the control group after 72 h. One patient in each group died before 72 h. Adjusted mean log IL-6 concentrations after 72 h were 0·30 higher in the cytokine adsorption group (95% CI -0·70 to 1·30, p=0·54). Survival after 30 days was three (18%) of 17 with cytokine adsorption and 13 (76%) of 17 without cytokine adsorption (p=0·0016). INTERPRETATION: Early initiation of cytokine adsorption in patients with severe COVID-19 and venovenous ECMO did not reduce serum IL-6 and had a negative effect on survival. Cytokine adsorption should not be used during the first days of ECMO support in COVID-19. FUNDING: None. |
Databáze: | OpenAIRE |
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