Vascular Calcification
Conditions
Brief summary
50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment. Serum samples will be drawn at baseline, after 4, 8 and 24 weeks. Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining. Primary endpoint: In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8. Secondary Endpoints: Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months Cell culture: Incubation of VSMC with serum samples obtained after 6 months * Alizarin staining/WST-8 * Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants * Apoptosis The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
Interventions
Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.
DEVICEHigh-Flux dialysis membrane
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years an older * Chronic dialysis patients for at least 3 months
Exclusion criteria
* Serum albumin \<32g/L at the last routine albumin measurement * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months | Six months | Serum samples will be drawn at the beginning of the trial and after six months treatment with either High-Flux or Medium Cut-Off filters. Vascular smooth muscle cells will be incubated with thee serum samples and calcification will be assessed with Alkaline Phosphatase/ WST8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Pulse wave velocity | Six months | Aortic Pulse wave velocity will be determined using the Vicorder Device. |
| Calcification propensity | Six months | Calcification propensity will be determined as described earlier. (PMID: 24179171) |
| Physical activity level | Six months | Physical activity level will be monitored for one week before and after treatment using an activity tracker. |
| Cell culture: Incubation of VSMC with serum samples and assessment of • Alizarin staining/WST-8 • Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants • Apoptosis | Six months | Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum. |
Countries
Germany
Outcome results
None listed