Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Effect of treatment on serum calcification propensity, measured by T50
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 111 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Intervention: Bicarbonate (Device)
Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Intervention: Magnesium (Device)
Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
Intervention: Bicarbonate (Device)
Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
Intervention: Magnesium (Device)
Outcomes
Primary Outcomes
Effect of treatment on serum calcification propensity, measured by T50
Time Frame: 7 weeks
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
Secondary Outcomes
- Number of participants with treatment-related adverse events(7 weeks)