Characterization of the DialGuard device for endotoxin removal in hemodialysis.
Bacterial pyrogens, capable of penetrating dialyzer membranes, are responsible for a systemic inflammatory reaction in hemodialysis patients. Dialyzer reuse, involving rinsing of the dialyzer with pyrogen-containing water, may exacerbate this situation. Studies of the mechanism of action of endotoxin suggest that it irreversibly damages the vascular endothelium. The novel endotoxin removal method described here, is based on affinity-binding of endotoxin by the adsorbent ClarEtox, a USP Class VI-certified resin that is the active component of the medical device DialGuard. Under standard hemodialysis operating conditions, challenge of DialGuard with Pseudomonas maltophilia supernatant-spiked dialysate, containing 35-193 EU/ml endotoxin, resulted in endotoxin levels below 0.05 EU/ml in the treated dialysate. DialGuard was able to decrease endotoxin concentrations in the dialysate from a range of 2.39-8.49 to <0.005 EU/ml. DialGuard supports high fluid velocities at low back pressures and can be sanitized using the heat sanitization cycle of hemodialysis machines. DialGuard offers a simple, user-friendly way to reduce the concentration of endotoxin in dialysate and water for dialysis at a low cost.
Szathmary
Susan
S
Clarigen, Inc., Carlsbad, CA 92008, USA.
Hegyi
Edit
E
Amoureux
Marie-Claude
MC
Rajapakse
Nandani
N
Chicorka
Lisa
L
Szalai
Gyorgy
G
Reszegi
Katalin
K
Derbyshire
Zachary
Z
Paluh
Janet
J
Dodson
Bryce
B
Grandics
Peter
P
D002846:Chromatography, Affinity; D004731:Endotoxins / Q000302:isolation & purification*; D015312:Hemodialysis Solutions / Q000009:adverse effects / Q000633:toxicity; D006801:Humans; D011549:Pseudomonas / Q000472:pathogenicity; D006435:Renal Dialysis / Q000009:adverse effects / Q000295:instrumentation*; D018746:Systemic Inflammatory Response Syndrome / Q000209:etiology / Q000517:prevention & control
D004731:Endotoxins; D015312:Hemodialysis Solutions