Abstract: PO2523
SCD Treatment in COVID-19 ICU Patients with ARDS and AKI Is Safe and May Improve Clinical Outcomes
Session Information
- Late-Breaking Clinical Trials Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Yessayan, Lenar Tatios, University of Michigan, Ann Arbor, Michigan, United States
- Neyra, Javier A., University of Kentucky, Lexington, Kentucky, United States
- Westover, Angela, University of Michigan, Ann Arbor, Michigan, United States
- Szamosfalvi, Balazs, University of Michigan, Ann Arbor, Michigan, United States
- Humes, H. David, University of Michigan, Ann Arbor, Michigan, United States
Background
ICU patients with COVID-19 with acute respiratory distress syndrome (ARDS) on mechanical ventilation (MV) and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) have very high mortality rates. Elevation of certain inflammatory mediators, including IL10 and soluble interleukin 1 receptor-like 1 (sST2), predict mortality in COVID-19 patients and declines as patients recover. Previous data have shown that treatment with a selective cytopheretic device (SCD) improves clinical outcomes in ARDS and severe AKI by removing proinflammatory leukocytes from circulation and reducing plasma levels of inflammatory cytokines. The aim of this feasibility study was to evaluate the safety and early efficacy of SCD treatment (Tx) in ICU COVID-19 patients with ARDS on MV and AKI requiring CRRT.
Methods
22 subjects were enrolled and treated with SCD for ≤10 days. 5 patients were treated less than 96 hours due to family's request for withdrawal of care. Patients were previously treated with remdesivir and corticosteroids. All but one patient were on both MV and CRRT with 10 patients on extracorporeal membrane oxygenation (ECMO). A subgroup of 8 patients was further evaluated with plasma inflammatory biomarkers and cell sorting/cytometric analysis (CSCA) of circulating neutrophils and monocytes. Clinical outcomes of SCD-treated patients were compared to untreated control patients on CRRT and mechanical ventilation in a contemporaneous, prospective observational data set (CRRTnet).
Results
Patients completed the study between September 2020 and July 2021. Mean age was 53±17 years (19-79). No device-related serious adverse events were reported. 60-day mortality in the SCD treated group was 11/22 (50%) vs.11/13 (85%) in the control group. CSCA demonstrated SCD removed the most activated circulating neutrophils (CD11b, CD10) and monocytes (CD11b, CD14). SCD Tx reduced baseline plasma levels of IL10 (12±9 pg/ml to 2±1, p<0.02) and sST2 (212±70 pg/ml to 88±74, p<0.02), as well as reducing plasma IL6 and MCP (Monocyte Chemotactic Protein)-1 levels.
Conclusion
SCD treatment is safe in ICU COVID-19 patients with ARDS on MV and AKI requiring CRRT. In this feasibility study, mortality rate was substantially lower than a concurrent control group, suggesting clinical benefit.
Funding
- Commercial Support – SeaStar Medical, Inc.