Hemodialysis
Conditions
Brief summary
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type. Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration. Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
Interventions
OTHERdialyzer comparison
Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.
DEVICEDialyzer
Comparison Dialyzer FX60 versus Cordiax60
Sponsors
Fresenius Medical Care Deutschland GmbH
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are treated by post dilution on-line HDF for at least three months. * Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks, * Patients who are on a stable anticoagulation and anemia management, * Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator, * Patients who are on a regular thrice weekly HDF schedule, * Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (\> 300 ml/min), * Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent, * Patients who are aged 18 years or older.
Exclusion criteria
* Patients who do not meet the inclusion criteria, * Patients with active HBV, HCV, HIV infection, * Patients who are severely malnourished patients as judged by the principal investigator, * Patients who are known or suspected to have allergy to the trial products or related products, * Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages), * Patients who have been diagnosed a current active malignant disease, * Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month, * Patients who are uncooperative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Removal rate of myoglobin | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Removal rate of phosphate | 2 weeks |
| Removal rate of ß2-microglobulin (ß2-m) | 2 weeks |
| Removal rate of prolactin | 2 weeeks |
| Removal rate of urea | 2 weeks |
| Removal rate of alpha1-acid glycoprotein | 2 weeks |
| Hematocrit pre and post-dialysis | 2 weeks |
| Albumin loss during dialysis session | 2 weeks |
| Removal rate of alpha1-microglobulin | 2 weeks |
Countries
Spain
Outcome results
None listed