Abstract: SA-PO648
Safety and Efficacy of a New Biomimetic Sorbent Hemoperfusion Device in Removing Bacteria from Hemodialysis Patients with Blood Stream Infections - Results of a Multicenter First-in-Human Study
Session Information
- Pharmacology
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
- 1700 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
Authors
- Eden, Gabriele C., Academic Teaching Hospital Braunschweig, Braunschweig, Germany
- Schmidt, Julius, Hannover Medical School, Hannover, Germany
- Büttner, Stefan, University hospital Frankfurt, Frankfurt am Main, Germany
- Rovas, Alexandros, University Hospital Münster, Münster, Germany
- Kümpers, Philipp, University Clinics Münster, Münster, Germany
- Schmidt, Bernhard M.W., Hannover Medical School, Hannover, Germany
- Kielstein, Jan T., Academic Teaching Hospital Braunschweig, Braunschweig, Germany
Background
Prompt reduction of bacterial load improves survial of bacteremic patients, so strategies above and beyound antibiotics are invesitagted. Binding of bacteria to heparan sulfate can be used to remove bacteria from the circulating blood by mimicking heparan sulfate grafting heparin to beads packed in a column. This device, the Seraph® 100 Blood Filter (Seraph), also removes toxins, and cytokines. Aim of this multicenter first in human study was to asses safety and efficacy of the Seraph in hemodialysis patients with bacteremia.
Methods
Fifteen (3F/12M, median age 75 [66-79] years) patients were included (www.clinicaltrials.gov. NCT02914132). The Seraph was placed in series, upstream from a dialyzer during a single four hour dialysis session. Vital signs as well as coordinates of the hemodialysis and a detailed laboratory analysis were performed. Efficacy was evaluated by measuring time to positivity in the blood cultures taken before and after the Seraph at several time points. Patient follow up was 14 days.
Results
As the last patient was enrolled before the abstract deadline complete data are only available in 14 patients. Vital signs remained stable and peripheral oxygen saturation improved during treatment unrelated to fluid removal. In patients with bacteremia at the time of treatment despite an adequate dose on antibiotics (4 out of 15), Seraph lead to a decrease in bacterial count.
Conclusion
Seraph treatment is well tolerated by hemodialysis patients, and can quickly remove bacteria 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. Improvement of oxygen saturation during treatment deserves further investigation.
Funding
- Commercial Support –