Sorbent Treatment Prescriptions Pilot Study (Sorb 2)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions|
- Treatment Adequacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: 2008 Sorbent system
Hemodialysis with the 2008 Sorbent system
Device: 2008 Sorbent System
2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).
No Intervention: single pass hemodialysis
routine single-pass high-flux hemodialysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437761
|Contact: Rebecca Apruzzese, MSfirstname.lastname@example.org|
|United States, New York|
|Yorkville Dialysis Center||Recruiting|
|New York, New York, United States, 10128|
|Contact: Laura Rosales, MD 212-870-9458 email@example.com|
|Sub-Investigator: Laura Rosales, MD|
|Principal Investigator:||Peter Kotanko, MD||Renal Research Institute|