Zuragen® Lock (an investigational device)

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Transcript Zuragen® Lock (an investigational device)

Zuragen® Lock (an
investigational device)
• Sodium Citrate 7%, Methylene Blue 0.050%,
and 0.165% parabens.
• Density same as blood, 1.040.
• To be used as routine catheter lock instead of
heparin.
• In vitro data showing eradication of all
planktonic and biofilm bacteria in one hour.
• Similar solution (methylene blue/4% citrate) has
been used for catheter salvage for 5 years in our
practice, acceptable results.
And physically eliminates biofilm
from plastic surfaces
Figure 4- Scanning Electron Microscopy (SEM) of P. aeruginosa biofilm
on polycarbonate coupons before (left) and after (right) one hour of
ZuragenTM treatment.
AZEPTIC™ Analysis: Time to CRBSI Events
Definite and Concordant CRBSI Events
1.00
0.99
Zuragen
0.98
0.97
0.96
0.95
0.94
0.93
Heparin
0.92
0.91
0.90
0
20
40
60
80
100
120
140
160
180
200
Days
Treatment
AAT-023
Heparin
Kaplan-Meier survival curves reinforce the statistically significant
has in the prevention of
CRBSI vs. heparin.
_____________________________________________________________________________________________________________________________________
AVERION International Corp. (April 16, 2009)
(p=0.0290)
efficacy ZuragenTM Solution
Source
Program: figures_km.sas
AZEPTIC™ Analysis: Time to Patency Failure
Heparin
Kaplan-Meier survival curves reinforce the significant (p=0.0423)
difference of ZuragenTM Solution in preventing catheter patency failures.
Primary Care Physicians Assure
Patients obtain Fistulas for Dialysis
• Preserve arm veins for hemodialysis access
• Expect and support access procedures at
stage 4-5 (GFR<20 ml/min/1.73M2)
• Avoid damage to fistula or graft in arm
• Monitor graft and fistula function, report
abnormalities
• Make sure dialysis catheter if present is
accessed only for dialysis procedures
Avoid IV Catheters in Arms
Avoid Venipunctures and Blood Pressure
Measurements in Arm with Fistula or Graft
• If patient has seen a nephrologist, ask if
they have a fistula or graft
• Roll up sleeve and look for scar and feel
for “thrill” at the scar site
• Use hand veins if possible.
Evaluate Fistula Function in the Office
If there is no thrill or pulsation in fistula or graft, it is clotted. Contact
Nephrologist or Dialysis Unit.
Peritoneal Dialysis Catheters are More
Successful than Tunneled CVC for
HemoDialysis
Kaplan-Meier plot of Tenckhoff catheter survival according to the technique
of placement, peritoneoscopic versus surgery.
Gadallah et al. Am J Kidney Dis 33:120, 1999.
Kaplan-Meier curves for catheter survival of peritoneoscopically (Scope) and
surgically (Surgery) placed peritoneal dialysis catheters in patients receiving
their first PD catheter.
Pastan, et al. Trans Am Soc Artif Intern Organs, 1991.
Tenckhoff catheters placed by
dissection also do very well
Ortiz et al. Outcome of peritoneal dialysis:
Tenckhoff catheter survival in a
prospective study. , Adv Perit Dial.
2004;20:145-9.
8. Choice of Therapy-What about Peritoneal Dialysis?
-use in the US is flat but may soon increase
-most home dialysis patients are on PD however
2010
Outcomes over 5 years are similar for
hemodialysis and peritoneal dialysis
How about in the hospital, how do we choose continuous
therapy versus hemodialysis for acute renal failure
patients?
NxStage Therapy System-Used in Lafayette for
Continuous Dialysis in the Hospital
Choice often is based
on practicalities and
risks rather than
clinical benefit
New Approaches to Making
Dialysis Simpler to Implement in
Homes
• Wearable hemodialysis systems
• Sorbent regeneration of peritoneal
dialysate
• Flow-through PD systems
• Sorbent regeneration of dialysate (6 liters
tap water used rather than over 100 liters
purified water)
Allient™ Sorbent Dialysis System
FDA Approved, New Version Being Constructed
Finally, thanks for the help in care
of these very complicated patients
• Nephrologists will become the primary
care physician for patients on dialysis or
after transplant
• But we really appreciate the care of many
medical problems by Family Practice and
Internal Medicine primary care physicians.
Thanks for the attention….