CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry

Abstract

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://ichgcp.net/clinical-trials-registry/NCT0439192, identifier: NCT04391920.

Trial registration: ClinicalTrials.gov NCT00439192 NCT04391920.

Keywords: CytoSorb; ECMO–extracorporeal membrane oxygenation; ICU–intensive care unit; coronavirus–COVID-19; hemoabsorption; hemoperfusion; inflammation; mortality.

Conflict of interest statement

This study received funding from the CytoSorbents Corporation. The funder had the following involvement with the study: MJ was employed by company Summit Analytical LLC. PN and ED are employees of the CytoSorbents Corporation (Princeton, NJ, USA). ZM is an employee of CytoSorbents Europe (Berlin, Germany). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Song, Hayanga, Durham, Garrison, McCarthy, Barksdale, Smith, Bartlett, Jaros, Nelson, Molnar, Deliargyris and Moazami.

Figures

Figure 1

Kaplan-Meier curve for ICU survival from start of CytoSorb therapy to 90 days. Survival following start of CytoSorb therapy was 82.7% (43/52) at 30 days and 73.1% (38/52) at 90 days.

Figure 2

Patient disposition from start of CytoSorb therapy to 90 days. Stacked Area Graph showing the disposition of the CTC cohort following start of CytoSorb therapy in the ICU.