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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential


TSX:EDT - Post by User

Post by mercedesmanon Mar 22, 2021 2:50pm
257 Views
Post# 32851560

Italian Covid/PMX Study

Italian Covid/PMX Study

Abstract

The coronavirus disease 2019 (COVID19) has been shown to involve the gastrointestinal tract, which implies bacterial translocation and endotoxemia. The aim of this study was to evaluate the role of extracorporeal endotoxin removal by Polymyxin B hemoperfusion (PMXHP), in the treatment of patients with COVID19 and secondary bacterial infection. We conducted a subgroup analysis of a multicenter, multinational, prospective, and observational webbased database (EUPHAS2 registry). We included 12 patients with severe acute respiratory syndrome coronavirus 2 infection confirmed by realtime reverse transcriptasepolymerase chain reaction from nasal/oral swab, admitted to the intensive care unit between February and May 2020, who were affected by septic shock and received PMXHP as per clinical indication of the attending physician. Septic shock was diagnosed in nine patients (75%), with a median time between symptoms onset and PMXHP treatment of 16 (1422) days. We identified Gramnegative bacteria in most of the microbiological cultures (N = 17, 65%), followed by Grampositive bacteria in (N = 4, 15%), fungi (N = 3, 12%) and no growth (N = 2, 8%). Sequential Organ Failure Assessment (SOFA) score progressively improved over the next 120 hours following PMXHP and it was associated with median endotoxin activity assay (EAA) decrease from 0.78 [0.700.92] at T0 to 0.60 [0.440.72] at T120 (P = .245). A direct correlation was observed between SOFA score and EAA. Lung Injury Score decreased and was associated with hemodynamic improvement over the same period. No statistically significant difference was observed for RIFLE score at each time point. Nine out of 12 patients (75%) required continuous renal replacement therapy because of acute kidney injury. In a series of consecutive COVID19 patients with endotoxic shock, PMXHP was associated with organ function recovery, hemodynamic improvement, and contemporary EAA level reduction. No PMXHPrelated complications were observed.

https://onlinelibrary.wiley.com/doi/full/10.1111/aor.13900


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