Chronic Kidney Failure, End Stage Renal Disease
Conditions
Keywords
Hemodialysis
Brief summary
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.
Interventions
DEVICEAllient System
The Allient System uses a different type of blood pump and a lower volume of dialysate.
Sponsors
Renal Solutions, Inc.
Renal Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Maintenance in-center hemodialysis * Age greater than or equal to 18 years * Has been on hemodialysis for at least 4 months * Uses a standard single-pass dialysis machine with a high-flux dialyzer
Exclusion criteria
* Hospitalization during the 8 weeks preceding enrollment * Infection requiring antibiotic treatment during the 8 weeks preceding enrollment * Central venous cather as dialysis access * Uncontrollable blood coagulation anomalies * Smokers * Dialysis regimen other than 3 times weekly * In ability to understand the English language and give informed consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of specific waste products from blood determined through subject blood and dialysate samples | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation as determined by levels of specific inflammatory markers | 3 weeks |
| Red blood cell lifespan determined through a measurement of CO in the subject's breath | 3 weeks |
Countries
United States
Outcome results
None listed