Clinical trial NCT01437761: Sorbent Treatment Prescriptions Pilot Study
Official title: Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Failure
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
Collaborators: name: Renal Solutions, Inc.
First posted: 2011-09-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage renal disease patients

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 filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.

This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.

How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.

Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Treatment Adequacy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References: