The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.
This trial is a prospective, non-randomized study in patients as an adjunctive treatment for blood stream infection (BSI) in patients on renal replacement therapy. The heparin surface being studied is currently marketed on extracorporeal circuits. It has been shown to absorb various types of Gram positive and Gram negative bacteria and to reduce toxins and cytokines in in vitro studies using whole blood. For this study, patients on renal replacement therapy who develop bacteremia will have the Seraph® 100 Microbind® Affinity Blood Filter included in the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory indices on the day of treatment and on post procedure day 1, 2, 3, 4, 5, 6, 7 and 14.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Treatment of renal replacement therapy patients with bacteremia.
Klinikum Braunschweig
Braunschweig, Germany
Universitaetsklinikum-Frankfurt
Frankfurt, Germany
Medizinische Hochschule-Hannover
Hannover, Germany
Universitatsklinikum Muenster
Münster, Germany
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.
Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured
Time frame: 14 days
Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.
Pathogen reduction of \> 40 % as CFU/mL or an increase in time to positivity (TTP) of \> 22 minutes in blood passed through the Seraph 100 Filter
Time frame: 4 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.