Status:
TERMINATED
Sorbent Treatment Prescriptions Pilot Study
Lead Sponsor:
Renal Research Institute
Collaborating Sponsors:
Renal Solutions, Inc.
Conditions:
Renal Failure
Eligibility:
All Genders
18-88 years
Brief Summary
This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.
Detailed Description
The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filteri...
Eligibility Criteria
Inclusion
- age \</=18 years
- end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for \</= 6 months at time of enrollment
- well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of \>/= 300 mL/min
- ability to understand the English language
Exclusion
- Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
- Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
- Active Infections
- Hepatitis B
- Any other active infection that has required antibiotic treatment in the preceding eight weeks
- Pre-study lab values of any of the following (in the most recent routine lab work)
- Sodium - Na+ \> 150 mmol/L, Na+ \< 132 mmol/L
- Potassium - K+ \> 6.5 mmol/L, K+ \< 3.5 mmol/L
- Total Calcium - Ca \> 12 mg/dL (3 mmol/L), total Ca \< 7.2 mg/dL (1.8 mmol/L)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01437761
Start Date
August 1 2011
End Date
January 1 2012
Last Update
April 12 2017
Active Locations (1)
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1
Yorkville Dialysis Center
New York, New York, United States, 10128