End Stage Renal Failure on Dialysis, Vascular Calcification
Conditions
Brief summary
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.
Interventions
DEVICEMagnesium
Magnesium in dialysate increased
DEVICEBicarbonate
Bicarbonate in dialysate increased
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 111 Years
Healthy volunteers
No
Inclusion criteria
* Male or female hemodialysis patients ≥ 18 years of age * Negative pregnancy test of female patients in child-bearing age * The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study * Start of chronic hemodialysis treatment ≥ 3 months ago * HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week * Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week * T50 ≥ 200 minutes.
Exclusion criteria
* Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age. * History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of treatment on serum calcification propensity, measured by T50 | 7 weeks | T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012) |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | 7 weeks |
Countries
Switzerland
Outcome results
None listed