Abstract: TH-PO910
First Treatment of Human Bacteremia during Dialysis Using a Biomimetic Sorbent Hemoperfusion Device
Session Information
- Dialysis: Infection
November 02, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Dialysis
- 610 Dialysis: Infection
Authors
- Kielstein, Jan T., Academic Teaching Hospital Braunschweig, Braunschweig, Germany
- White, Kathleen A., ExThera Medical, Martinez, California, United States
- McCrea, Keith, ExThera Medical, Martinez, California, United States
- Ward, Robert S., ExThera Medical, Martinez, California, United States
Background
Blood stream infections are the 2nd leading cause of mortality among CKD5D patients. To subvert the host immune response many pathogens bind to heparan sulfate, a key receptor on cell surfaces. The Seraph® 100 Blood Filter (Seraph) uses this affinity to bind and remove pathogens, toxins, and cytokines from flowing blood.
Methods
The first patients treated with the Seraph as part of an ongoing first-in-man study (www.clinicaltrials.gov. NCT02914132) are presented. The Seraph was placed in series, upstream from a FX80 high-flux dialyser (FMC), during a regular hemodialysis procdure with a 5008H dialysis machine (FMC) (Qb 300 mL/min; Qd 500 mL/min).
Results
Two male hemodialysis patients 57 and 82 years of age presented with S. aureus bacteremia. In adjunction to antibiotic therapy they were treated with Seraph concurrent with hemodialysis. As measured by automated blood culture, post-Seraph/pre-dialyzer blood samples had increased time to positivity (TTP) relative to contemporaneous pre-Seraph samples, indicating reduced concentration of bacteria. As estimated from TTP, mean incoming blood-borne bacteria decreased by 99% and 47% respectively per pass through the Seraph cartridge. During the 4-hour in-series treatment with Seraph and a dialyzer both patients remained hemodynamically stable and showed no adverse reactions. Heart rate, blood pressure, and cardiac output were stable and reproducible. No clinically significant post treatment-changes in hematology or clinical chemistry occurred.
Conclusion
Seraph appears to be well tolerated by patients, and is capable of quickly removing pathogens from blood. It’s rapid, broad-spectrum binding and inherent blood compatibility suggest future use as a prophylactic, or at the first sign of bloodstream infection, even before pathogen identification.
Funding
- Commercial Support –